| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology | ||
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology | ||
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology |
Recent Updates
Recently added Catalysts
Elutia, Inc.$0.96
-0.01 (-0.93%)
F 9Pipeline Score Biotech · Commercial
Market Cap
51.28 M
EPS
-0.63
P/E Ratio
-
Value Trade
146.24 K
SEC Financials
Q1 2026Dilution Risk
40%Revenue
3.11 M
R&D Expenses
1.97 M
Operating CF
-7.83 M
Total Assets
55.21 M
Total Liabilities
32.68 M
Equity
22.53 M
D/E Ratio
12,345
16 %
Week
-0.85 %
1 Month
5.45 %
3 Month
93.01 %
6 Month
-90.21 %
5 Year
-93.3 %
All Time
Cash Data
Cash Position
28.49 M
Monthly Burn
2.61 M
Runway
9.3 mo
Burn Trend
SEC Filing
May 15, 2026
Overview
Volume
7.90 K
52 Week Range
0.50 - 2.64
% held by Insiders
20.1 %
% held by Institutions
28.58 %
Enterprise Value
34.39 M
Total Shares
44.23 M
Short %
0.16 %
Float Shares
32.15 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Elutia, Inc.
171Total events
5Upcoming
44Tier-1 (high impact)
2020 – 2027Coverage
Upcoming catalysts 5
Event history 166
Q3 2026
◆FDA Filing AcceptedNXT-41Regulatory Filing
FDA clearance for NXT-41 base matrix
breast reconstructionsource ↗
Jun 17, 2026
◆Oral PresentationPresentation
Elutia to present at Planet MicroCap Showcase 2026
post-surgical infection in implant-based breast reconstructionsource ↗
May 18, 2026
May 14, 2026
Q2 2026
◆FDA Filing AcceptedNXT-41Regulatory Filing
Anticipated FDA clearance for NXT-41
breast reconstructionsource ↗
Q2 2026
◆Product LaunchNXT-41Post-Market
Initial product launch of NXT-41 platform for breast reconstruction
breast reconstructionsource ↗
Q2 2026
◆FDA Feedback ReceivedNXT-41FDA Meeting
FDA clearance of base matrix for NXT-41 platform
breast reconstructionsource ↗
Q1 2026
▲Manufacturing MilestoneNXT-41xCMC / Inspection
New automated manufacturing process brought online for NXT-41x
Mar 19, 2026
◆Oral PresentationPresentation
Elutia management presentation at Sidoti Small-Cap Virtual Investor Conference
post-surgical infection in implant-based breast reconstructionsource ↗
Mar 11, 2026
Drug Pipeline Intelligence
F9
Pipeline Score -
Pipeline ValueValuation Signal
0
Drugs Scored—
rNPV / MCap Top 6%
Micro Cap (rank 857 of 911)
Percentile RankElutia, Inc. has significant pipeline risk (9/100).
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
antibiotic-eluting biologic envelopes | management of cardiac implantable electronic devices (CIEDs) | — | 2025-09-16 | overall procedural difficulty reduction: 43%; easier generator mobilization: 46%; easier lead mobilization: 41% Read More | Elutia Announces Newly Published Clinical Data Demonstrating that Biologic Envelopes Support CIED Stabilization and Ease of Reoperation Read More | |
antibiotic-eluting biologic envelopes | management of cardiac implantable electronic devices (CIEDs) | — | 2025-09-16 | overall procedural difficulty reduction: 43%; easier generator mobilization: 46%; easier lead mobilization: 41% Read More | Elutia Announces Newly Published Clinical Data Demonstrating that Biologic Envelopes Support CIED Stabilization and Ease of Reoperation Read More | |
antibiotic-eluting biologic envelopes | management of cardiac implantable electronic devices (CIEDs) | — | 2025-09-16 | overall procedural difficulty reduction: 43%; easier generator mobilization: 46%; easier lead mobilization: 41% Read More | Elutia Announces Newly Published Clinical Data Demonstrating that Biologic Envelopes Support CIED Stabilization and Ease of Reoperation Read More |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in ELUT
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
ELUT Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
ELUT▼ -8%on this news
Elutia to Present at Planet MicroCap Showcase 2026 on June 17th
Elutia Inc. will present at the Planet MicroCap Showcase 2026 on June 17-18, 2026, in Las Vegas. CEO Dr. Randy Mills and CSO Dr. Michelle Williams will discuss their innovative drug-eluting biomatrix technology aimed at reducing post-surgical infections in breast reconstruction. The event includes one-on-one meetings with investors, emphasizing Elutia's commitment to improving patient outcomes.
Read more →ELUT▲ +6.8%on this news
Elutia Announces Grants of Inducement Awards under Nasdaq Listing Rule 5635(c)(4)
Elutia Inc. has announced the granting of equity awards under the 2026 Inducement Award Plan, with 48,000 non-qualified stock options issued to a new employee. The options vest over four years and were granted at the Nasdaq closing price of $1.05 per share. This initiative aligns with Nasdaq Listing Rule 5635(c)(4) and reflects Elutia's commitment to compliance and growth in the burgeoning field of drug-eluting biomatrix technologies.
Read more →ELUTElutia to Present at the 16th Annual LD Micro Invitational on May 18th
Elutia Inc. will present at the 16th Annual LD Micro Invitational on May 18, 2026. CEO Dr. Randy Mills and CFO Matt Ferguson will discuss their innovative drug-eluting biomatrix technology aimed at reducing post-surgical infections in breast reconstruction. The presentation will highlight the company's commitment to improving patient outcomes in this area.
Read more →ELUTElutia Reports First Quarter 2026 Results and Highlights NXT-41x Progress Toward $1.5 Billion U.S. Plastic and Reconstructive Surgery Market
Elutia Inc. reported its first quarter 2026 results, highlighting progress on NXT-41x, an antibiotic-eluting product aimed at the reconstructive surgery market. The FDA review for NXT-41 is advancing, with anticipated clearance in late 2026. The company has also implemented a new automated manufacturing process aimed at achieving gross margins above 80%. Despite these advancements, Elutia reported a net loss of $7.9 million for the quarter.
Read more →ELUTElutia to Report First Quarter 2026 Financial Results on Thursday, May 14, 2026
Elutia Inc. has announced it will release its first quarter financial results for 2026 on May 14, 2026. The company will host a conference call and webcast to discuss these results, aimed at keeping investors informed. With an emphasis on drug-eluting biomatrix technologies, Elutia seeks to enhance patient compatibility with medical devices, reflecting its mission to humanize medicine.
Read more →ELUTElutia to Present at Sidoti’s Small-Cap Virtual Investor Conference March 18-19
Elutia Inc. will present at the Sidoti Small-Cap Virtual Investor Conference on March 18-19, 2026. The CEO and CFO will discuss the company’s efforts in addressing post-surgical infections in implant-based breast reconstruction, a critical area for patient recovery. This presentation aims to inform investors about the potential impact of Elutia's drug-eluting biomatrix technology, designed to enhance surgical outcomes. The event highlights Elutia's commitment to improving patient care in the field of reconstructive medicine.
Read more →ELUTElutia Reports Fourth Quarter and Full Year 2025 Financial Results; Initiates NXT-41 Regulatory Process - Base biologic matrix NXT-41 submitted to FDA; on track for anticipated FDA clearance in second half of 2026 and fu
Elutia Inc. has reported its fourth quarter and full year 2025 financial results, highlighting a successful submission of its base biologic matrix, NXT-41, to the FDA and anticipating its clearance by late 2026. The company generated $44.4 million in cash at year-end, following the divestiture of the BioEnvelope business to Boston Scientific, which has allowed Elutia to eliminate debt and refocus on its core operations. CEO Dr. Randy Mills expressed confidence in the company's prospects and its mission to improve outcomes in breast reconstruction procedures.
Read more →ELUTElutia Regains Compliance with Nasdaq Listing Requirements
Elutia Inc. has announced that it has regained compliance with Nasdaq's listing requirements, specifically regarding minimum bid price and market value. The company’s Class A common stock will continue to be listed on the Nasdaq Capital Market. CFO Matt Ferguson expressed optimism about the increase in share price, attributing it to investor confidence in their drug-eluting biomatrix technology.
Read more →ELUTElutia Selects Pete Ligotti as CCO to Lead the Commercial Launch of NXT-41x and Transform Post-Mastectomy Care in the $1.5B U.S. Breast Surgery Market
Elutia Inc. has appointed Pete Ligotti as Chief Commercial Officer to spearhead the launch of NXT-41x, a next-generation antibiotic-eluting biomatrix aimed at improving outcomes in breast reconstruction surgery. With over 162,000 procedures performed annually in the U.S., the company sees a significant market opportunity. NXT-41x is expected to receive FDA clearance in 2027, addressing persistent infection rates in existing surgical practices.
Read more →ELUT▲ +5.5%on this newsshared move
Elutia to Report Fourth Quarter 2025 Financial Results on Wednesday, March 11, 2026
Elutia Inc. will announce its fourth quarter 2025 financial results on March 11, 2026. The company will host a conference call and webcast at 5:00 p.m. ET on the same day. This event will provide insights into the company's performance and future direction.
Read more →ELUTWhere Purpose Meets Performance: Elutia Earns 2026 Great Place to Work Certification™
Elutia Inc. has achieved the Great Place to Work Certification, highlighting its strong workplace culture and employee satisfaction. The company emphasizes excellence and diversity, with a significant portion of its workforce being women in leadership roles. Employees express pride in their impactful work, particularly in developing innovative medical technologies. This recognition underscores Elutia's commitment to fostering a high-trust environment.
Read more →ELUTElutia Reports Preliminary Fourth Quarter 2025 Results, Strengthened Financial Position, and Upcoming NXT-41x Milestones Fourth quarter revenue up 16% year-over-year, $26.9M of secured debt eliminated, and total cash and
Elutia Inc. reported a 16% increase in revenue for the fourth quarter of 2025 and eliminated $26.9 million of secured debt, highlighting its strengthened financial position. The company is advancing its NXT-41x program, which targets reducing post-operative infection rates in breast reconstruction. Elutia plans to submit an FDA filing for NXT-41 in 2026 and aims for clearance for NXT-41x in 2027, following the successful sale of its EluPro product. The financial information provided is preliminary and subject to change due to ongoing accounting procedures.
Read more →ELUTElutia to Present at Global BioInnovation Forum on NXT-41x Biomatrix Program for Plastic and Reconstructive Surgery
Elutia Inc. will present its NXT-41x biomatrix program at the Global BioInnovation Forum on January 13, 2026. This program aims to improve outcomes in plastic and reconstructive surgery by addressing high postoperative infection rates. The presentation will feature insights from Dr. Christopher Reid, highlighting the urgent need for advancements in breast reconstruction.
Read more →ELUTElutia Reports Third Quarter 2025 Financial Results; Closes $88 Million Sale of BioEnvelope Business to Boston Scientific Corporation; Funds NXT-41x Development
Elutia Inc. reported its third quarter 2025 financial results and announced the successful sale of its BioEnvelope business to Boston Scientific for $88 million. The company is focused on developing NXT-41x, a product aimed at addressing unmet needs in plastic and reconstructive surgery. CEO Dr. Randy Mills highlighted the importance of their antibiotic-eluting technology in preventing infections during breast reconstruction procedures.
Read more →ELUTElutia to Report Third Quarter 2025 Financial Results on Thursday, November 6, 2025
Elutia Inc. has announced that it will release its third quarter 2025 financial results on November 6, 2025. The company's management will host a conference call and webcast at 5:00 p.m. ET to discuss these results. This event reflects Elutia's commitment to keeping investors informed about its financial performance.
Read more →ELUTElutia to Present at the LD Micro Main Event XIX Conference on Tuesday, October 21
Elutia Inc. announced that its CEO, Dr. Randy Mills, will present at the LD Micro Main Event XIX Conference on October 21, 2025. The presentation will take place in San Diego and will be followed by 1x1 investor meetings. Elutia aims to enhance medical device compatibility through its drug-eluting biomatrix products.
Read more →ELUTElutia Appoints Accomplished MedTech Veteran Guido J. Neels to Board of Directors
Elutia Inc. has appointed Guido J. Neels to its Board of Directors, enhancing its leadership with his 40 years of experience in the medical technology sector. Neels will also serve on the audit committee. His appointment comes as the company aims to leverage its drug-eluting biomatrix technology for future innovations, particularly in breast reconstruction.
Read more →ELUTElutia Announces Closing of BioEnvelope Business Sale to Boston Scientific Corporation for $88 Million
Elutia Inc. has successfully closed the sale of its BioEnvelope business to Boston Scientific for $88 million. This strategic move aims to enhance Elutia's focus on its NXT-41x biomatrix, designed to address complications in breast reconstruction. The company anticipates launching NXT-41x in the first half of 2027, tapping into a significant market opportunity.
Read more →ELUTElutia Announces Newly Published Clinical Data Demonstrating that Biologic Envelopes Support CIED Stabilization and Ease of Reoperation
Elutia Inc. has published new clinical data demonstrating that their antibiotic-eluting biologic envelopes enhance the management of cardiac implantable electronic devices (CIEDs). The HEAL study shows that these envelopes reduce procedural difficulties by up to 43%, improving both device stabilization and surgical access. The findings suggest a promising future for this technology in addressing infection and procedural challenges.
Read more →ELUT▼ -21.5%on this news· ran to -32% by day 3
Elutia Announces Sale of BioEnvelope Business to Boston Scientific Corporation for $88 Million
Elutia Inc. has announced the sale of its BioEnvelope business to Boston Scientific for $88 million, which will fully fund the advancement of its NXT-41 product aimed at breast reconstruction. This transaction is expected to close in Q4 2025 and positions Elutia to eliminate debt and focus on its drug-eluting pipeline. The company will provide further updates at the upcoming H.C. Wainwright conference.
Read more →ELUT▼ -21.5%on this news· ran to -32% by day 3shared move
Elutia Announces Sale of BioEnvelope Business to Boston Scientific Corporation for $88 Million - Transaction affirms the strength of Elutia's proprietary drug-eluting biologics platform and fully funds advancement of NXT
Elutia Inc. announced the sale of its BioEnvelope business to Boston Scientific Corporation for $88 million. This deal highlights the effectiveness of Elutia's drug-eluting biologics platform and will fully fund the development of its NXT-41 program for breast reconstruction. The transaction is projected to close in the fourth quarter of 2025 and is seen as a significant advancement for the company’s financial health. Elutia will provide further updates at the upcoming H.C. Wainwright Annual Global Investment Conference.
Read more →ELUTElutia Selected to Exhibit EluPro™ Antibiotic Eluting BioEnvelope at Vizient Innovative Technology Exchange
Elutia Inc. has been selected to showcase its EluPro Antibiotic-Eluting BioEnvelope at the Vizient Innovative Technology Exchange on September 17, 2025. This technology is the first FDA-cleared bioenvelope designed for cardiac implantable electronic devices and neurostimulators, combining a biologic scaffold with antibiotics. The event aims to connect healthcare leaders with innovative products that enhance clinical outcomes.
Read more →ELUT▼ -7.9%on this news
Elutia to Participate in Upcoming Investor Conferences
Elutia Inc. has announced its participation in several upcoming investor conferences in New York. Dr. Randy Mills and Matt Ferguson will represent the company at the Cantor Global Healthcare Conference, H.C. Wainwright 27th Annual Global Investment Conference, and Lake Street Capital Markets 9th Annual Best Ideas Growth Conference. These events aim to enhance investor engagement and showcase Elutia's innovative drug-eluting biomatrix technologies.
Read more →ELUT▼ -6%on this news
Elutia Delivers Robust Growth on the Strength of EluPro™ Market Adoption
Elutia Inc. reported a 49% sequential revenue growth for its EluPro product in Q2 2025, driven by strong market adoption and strategic partnerships. The company is expanding its presence in over 160 VAC-approved hospitals and is advancing its next-generation NXT-41 biomatrix for breast reconstruction, with FDA clearance anticipated in 2026 and 2027. Elutia aims for a significant market impact in the breast reconstruction sector.
Read more →ELUTElutia Delivers Robust Growth on the Strength
Elutia Inc. reported significant growth in its second quarter of 2025, with EluPro revenue up 49% sequentially, driven by strong market adoption and an expanding customer base. The company has expanded its product approval to over 160 hospitals and is poised to launch its next-generation drug-eluting biomatrix, NXT-41, targeting breast reconstruction in late 2026. Additionally, Elutia's CEO anticipates that BioEnvelope sales will approach a $20 million annual run rate by year-end, demonstrating continued progress and potential in its market strategy.
Read more →ELUTDr. Michelle LeRoux Williams Earns Washington Business Journal’s Medical Device Innovator Award
Elutia Inc. announced that Dr. Michelle LeRoux Williams has received the Medical Device Innovator Award from the Washington Business Journal. This award highlights her leadership in developing EluPro, the first FDA-cleared antibiotic-eluting bioenvelope for cardiac devices. Dr. Williams emphasized the collaborative effort behind EluPro's success, which aims to improve patient outcomes in the medical device industry.
Read more →ELUTElutia to Report Second Quarter 2025 Financial Results on Thursday, August 14, 2025
Elutia Inc. has announced that it will release its second quarter 2025 financial results after the market closes on August 14, 2025. A conference call and webcast will follow at 5:00 p.m. Eastern Time, allowing investors to engage with the company's management. Elutia focuses on drug-eluting biomatrix technologies, aiming to enhance the compatibility of medical devices for patients.
Read more →ELUTNew Evidence Supports the Value of Elutia’s Antibiotic-Eluting Platform for Implantable Devices
Elutia Inc. has published a study demonstrating the effectiveness of its antibiotic-eluting EluPro BioEnvelope for cardiac implantable electronic devices (CIEDs). The study highlights the biomatrix's ability to control inflammation and support vascularization, leading to improved healing and reduced risk of infection. The findings suggest a significant advancement in addressing implant-related complications.
Read more →ELUTElutia Wins Dual Honors for Innovation and Product Launches at 2025 Medical Device Network Excellence Awards
Elutia Inc. has been awarded for its achievements at the 2025 Medical Device Network Excellence Awards, recognizing the innovation of its EluPro Antibiotic-Eluting BioEnvelope and its successful product launches. Since its pilot launch in September 2024 and subsequent commercialization in January 2025, EluPro has shown strong sales growth and significant acceptance in the medical community. This recognition underscores Elutia's commitment to enhancing safety and efficacy in cardiac implantable electronic devices and neurostimulation systems.
Read more →ELUTElutia Strengthens Drug-Eluting Biomatrix Platform with Peer-Reviewed Publication of Novel EluPro™ Testing Method
Elutia Inc. has announced the publication of a peer-reviewed article detailing a novel method for measuring antibiotic release from its EluPro platform, which is designed for drug-eluting biomatrices. This method provides comparable results to traditional testing but in significantly less time and at reduced costs. The validated approach is expected to support the lifecycle and development of future products with EluPro being the only FDA-cleared antibiotic-eluting bioenvelope available. The announcement underscores Elutia's leadership and commitment to advancing drug-eluting technologies.
Read more →ELUTElutia Announces Strong First Quarter 2025 Financial Results Driven by 84% Sequential Growth in EluPro™ Sales
Elutia Inc. reported strong first-quarter results for 2025, with EluPro sales surging by 84% sequentially. The company has established a new partnership with Boston Scientific to enhance market access. Despite a 10% decrease in overall net sales, EluPro's performance and recognition through awards highlight its potential in the cardiac device market.
Read more →ELUTElutia Announces Strong First Quarter 2025 Financial Results Driven by 84% Sequential Growth in EluPro Sales - New Boston Scientific distribution partnership now underway - - Conference call today at 5:00 p.m. ET / 2:00
Elutia Inc. has reported strong financial results for the first quarter of 2025, with EluPro achieving an impressive 84% sequential growth in sales. This growth positions EluPro as a key solution in the market for cardiac implantable electronic devices. The company is enhancing its efforts through a partnership with Boston Scientific to broaden their reach and improve patient outcomes. A conference call has been scheduled to discuss these results and future strategies.
Read more →ELUT▼ -7.7%on this news
Elutia Transitions to Direct Distribution of Its Cardiovascular Product Portfolio
Elutia Inc. has announced its transition to direct distribution of its cardiovascular product portfolio, including ProxiCor, VasCure, and Tyke. This strategic move follows the end of its distribution agreement with LeMaitre Vascular and aims to enhance revenue and profitability. The company has appointed Dwayne Montgomery to lead the new business unit, supported by a dedicated team of sales representatives. Elutia anticipates significant growth in this segment, with high gross margins expected.
Read more →ELUTElutia to Report First Quarter 2025 Financial Results on Thursday, May 8, 2025
Elutia Inc. has announced that it will release its first quarter financial results for 2025 on May 8, 2025, following the market's close. A conference call and webcast will commence that same day at 5:00 p.m. Eastern Time. This event aims to provide investors with insights into the company's performance and future outlook. Elutia specializes in drug-eluting biomatrix technologies to enhance the compatibility of medical devices for patients.
Read more →ELUTElutia Transitions to Direct Distribution of Its Cardiovascular Product Portfolio Move expected to drive both top-line growth and gross margin improvement
Elutia Inc. has announced its transition to direct distribution of its cardiovascular product portfolio, following the end of its agreement with LeMaitre Vascular, Inc. This shift aims to increase top-line revenue and improve gross margins for products like ProxiCor and VasCure. The company has appointed Dwayne Montgomery to lead the new business unit, emphasizing a focused approach with a dedicated sales team. This strategic move is expected to foster greater control and profitability within the cardiovascular segment.
Read more →ELUTElutia to Participate in Chardan’s Trending Issues in Drug Development Conference Series on April 29
Elutia Inc. announced that its Chief Scientific Officer, Dr. Michelle LeRoux Williams, will participate in Chardan's Trending Issues in Drug Development Conference on April 29, 2025. The event will focus on regulatory catalysts and the evolving landscape of drug development. This participation highlights Elutia's efforts in drug-eluting biomatrix technologies aimed at improving medical device compatibility. A live webcast of the event will be available on Elutia's investor website.
Read more →ELUTElutia Initiates EluPro™ Registry Study Designed to Generate Evidence Supporting the Use of EluPro in Real-World Clinical Practice
Elutia Inc. has launched a clinical study for its EluPro™ product, aimed at gathering real-world patient outcome data during CIED procedures. The study will evaluate performance across diverse patient populations and will monitor complications like infection and device migration. EluPro, which combines antibiotics with a regenerative biomatrix, seeks to differentiate itself in the cardiac device market, which faces significant complication rates. The first patient was enrolled at UC San Diego Health, with plans to include 100 patients over 12 months.
Read more →ELUT▼ -7.4%on this news
Elutia Confirms No Material Impact from Global Tariffs
Elutia Inc. has announced that the ongoing global tariff environment has not affected its commercial or operational performance. The company's operations are entirely based in the U.S., utilizing domestic manufacturing and suppliers, which has insulated it from tariff-related disruptions. CEO Dr. Randy Mills emphasized the reliability of their manufacturing and product delivery, ensuring that patients can continue to benefit from their medical products. Elutia's manufacturing facility in Roswell, Georgia is FDA-registered and has not faced any issues related to tariffs.
Read more →ELUT▼ -6.9%on this news
EluPro™ Named as 2025 Edison Award Winner
Elutia Inc. announced that its product EluPro, an antibiotic-eluting bioenvelope, received the 2025 Bronze Edison Award for its innovative design aimed at reducing post-surgical complications. Launched in January 2025, EluPro is FDA-cleared for use with major cardiac implanted electronic devices and neurostimulation devices. The award highlights Elutia's commitment to improving patient outcomes.
Read more →ELUT▲ +10.8%on this newsshared move
Elutia to Debut EluPro™ at HRS 2025 — Experience the Difference Biology Makes
Elutia Inc. has announced the debut of its EluPro Antibiotic-Eluting BioEnvelope at the Heart Rhythm Society's annual meeting in San Diego, scheduled for April 25-27, 2025. The EluPro product aims to enhance the compatibility of cardiac implantable electronic devices with a soft, conforming biomatrix while delivering antibiotics to reduce bacterial colonization. The company seeks to engage physicians by allowing them to experience the product firsthand and highlight its potential benefits in infection control. However, there are inherent risks related to commercialization and legal challenges that the company may face as they move forward.
Read more →ELUTElutia Announces GPO Agreement with Advantus Health Partners to Expand Access to EluPro™
Elutia Inc. announced a new agreement with Advantus Health Partners to enhance access to its EluPro Antibiotic Eluting BioEnvelope, marking the company's seventh such agreement since the product's launch. This partnership aims to meet high demand from healthcare providers for EluPro, which has been well received in pilot tests. The product is the first antibiotic-eluting biologic envelope cleared by the FDA for use with cardiac implantable electronic devices, enhancing patient outcomes by addressing infection risks and other complications. Elutia continues to pursue initiatives to grow its market presence through strategic collaborations.
Read more →ELUTElutia Advances Scientific Leadership with Publication of New Study on Antibiotic-Eluting Biologic Envelope
Elutia Inc. announced the publication of new preclinical data demonstrating the effectiveness of its antibiotic-eluting biologic envelope designed to prevent infections in cardiac implanted electronic devices (CIEDs). The study showed complete eradication of various bacterial strains and indicated a promising approach for enhancing patient outcomes. This product, known as EluPro, was commercially launched in the U.S. in January 2025 and aims to set a new standard in the treatment of CIED infections.
Read more →ELUT▲ +8.8%on this news· ran to +22% by day 3
Elutia Announces Fourth Quarter and Full Year 2024 Financial Results: Strong Demand for EluPro™ in Pilot Launch Sets the Stage for Full Commercial Roll-Out
Elutia Inc. reported strong financial results for Q4 and full year 2024, highlighting significant demand for its EluPro product. The company achieved an 18% increase in BioEnvelope sales and expanded its market presence with 67 approved accounts. Despite a net loss of $54.1 million, Elutia's pilot launch of EluPro has shown promising uptake among healthcare providers.
Read more →ELUT▼ -9.3%on this newsshared move
Elutia Announces Fourth Quarter and Full Year 2024 Financial Results: Strong Demand for EluPro in Pilot Launch Sets the Stage for Full Commercial Roll-Out - Overall BioEnvelope sales up 18%, with same-center sales increa
Elutia Inc. announced its fourth quarter and full year 2024 financial results, highlighting the strong demand for its FDA-cleared product, EluPro. Following its pilot launch, EluPro has gained significant traction with healthcare professionals and is contributing to a larger sales increase in the BioEnvelope product line. Full year 2024 financial results show an overall 18% increase in BioEnvelope sales and a remarkable 65% rise in same-center sales post-EluPro commercialization. The company is optimistic about the future, bolstered by strategic relationships and market potential.
Read more →ELUTElutia to Report Fourth Quarter and Full Year 2024 Financial Results on Thursday, March 6, 2025
Elutia Inc. has announced that it will be reporting its fourth quarter and full year financial results for 2024 on March 6, 2025. The company, known for its drug-eluting biomatrix technologies, aims to improve medical device compatibility for patients. A conference call will follow the results announcement, allowing investors to engage with the management team. The event will also be available via a live and archived webcast on the company's website.
Read more →ELUT▼ -14.3%on this news
Elutia Announces $15.0 Million Registered Direct Offering
Elutia Inc. has announced a $15.0 million registered direct offering involving 5,520,000 shares of Class A common stock at $2.50 per share. Additionally, the company will issue 480,000 prefunded warrants at a price of $2.499 each, which are immediately exercisable. The proceeds from this offering are intended for working capital and general corporate purposes, with the transaction expected to close by February 4, 2025, subject to customary conditions.
Read more →ELUT▼ -6.7%on this news
Elutia Announces Full Launch of EluPro™ Following Strong Initial Demand
Elutia Inc. has announced the full commercial launch of EluPro™, an FDA-cleared antibiotic-eluting biomatrix designed for use with implantable cardiac devices and neurostimulators. Following a successful pilot program, EluPro is anticipated to address infection prevention and promote healing for patients with these devices. Initial physician adoption has been strong, evidenced by the increase in orders after the product's value analysis committee approval. This launch represents a significant development in the field of electrophysiology and aims to improve patient outcomes.
Read more →ELUTElutia Announces EluPro™ GPO Agreement with Southern Strategic Sourcing Partners
Elutia Inc. has announced a partnership with Vizient to provide its EluPro™ Antibiotic Eluting BioEnvelope to Southern Strategic Sourcing Partners (S3P), facilitating access to the product in 993 acute care facilities. This is a significant step for Elutia as it prepares for the full commercial launch of EluPro, which is the first antibiotic-eluting biologic envelope cleared by the FDA for specific medical devices. The collaboration is expected to enhance the company’s reach and impact in the healthcare sector, allowing more patients to benefit from this innovative technology.
Read more →ELUTElutia Awarded Cardiac Rhythm Management Devices Agreement with Premier, Inc.
Elutia Inc. has secured a national group purchasing agreement for its EluPro™ Antibiotic-Eluting BioEnvelope with Premier, Inc., effective November 15, 2024. This agreement will facilitate access to EluPro for members of Premier, which serves a significant portion of U.S. healthcare providers. EluPro represents a significant advancement in cardiac rhythm management by combining antibiotic benefits with an extracellular matrix bioenvelope designed to improve recovery outcomes. The collaboration underscores a commitment by both companies to enhance healthcare quality through innovative solutions.
Read more →ELUT▼ -7%on this news
Elutia Announces Strong Third Quarter Results, Accelerating Toward Full Launch of EluPro® Antibiotic-Eluting BioEnvelope in 2025
Elutia Inc. reported strong third quarter results, highlighting the first commercial use of its EluPro antibiotic-eluting bio-envelope. The product has gained traction across major cardiac implantable electronic device brands, with over 100 submissions to hospital VACs. Despite a slight decline in overall net sales, the company anticipates a full launch of EluPro in January 2025, driven by positive market interest.
Read more →ELUTElutia Announces Strong Third Quarter Results, Accelerating Toward Full Launch of EluPro Antibiotic-Eluting BioEnvelope in 2025 Over 100 EluPro VAC Submissions and 19% SimpliDerm Growth Drive Momentum into 2025
Elutia Inc. reported strong third quarter results as it prepares for the full launch of its EluPro antibiotic-eluting BioEnvelope in January 2025. The company highlighted the successful first implant of EluPro and a notable increase in SimpliDerm's growth. With over 100 submissions for EluPro VAC and strong clinical interest, Elutia aims to redefine the BioEnvelope market. However, it acknowledged potential risks related to product liability, regulatory approvals, and dependence on third-party suppliers, which could impact its future performance.
Read more →ELUTElutia to Participate at the Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum
Elutia Inc. will participate in the Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum on November 21, 2024. Key executives, including Dr. Randy Mills, will hold one-on-one meetings with institutional investors. This event underscores Elutia's commitment to enhancing investor relations and showcasing its innovative drug-eluting biomatrix products.
Read more →ELUTElutia to Participate at the Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum
Elutia Inc. (Nasdaq: ELUT) has announced its participation in the Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum taking place in New York on November 21, 2024. Dr. Randy Mills, CEO, CFO Matt Ferguson, and CSO Dr. Michelle LeRoux Williams will meet with institutional investors during the conference. Elutia specializes in developing drug-eluting biomatrix products to improve medical device compatibility with patients. This engagement reflects the company's focus on advancing technologies to support an increasing patient population.
Read more →ELUTElutia to Report Third Quarter 2024 Financial Results on Thursday, November 14, 2024
Elutia Inc. will announce its third quarter 2024 financial results on November 14, 2024, after the market closes. The management team will host a conference call and webcast at 4:30 p.m. ET the same day for investors. The company focuses on drug-eluting biomatrix products to enhance compatibility between medical devices and patients.
Read more →ELUTElutia to Present at the LD Micro Main Event XVII Conference on Wednesday, October 30
Elutia Inc. has announced that Dr. Randy Mills, the President and CEO, will present at the LD Micro Main Event XVII Conference in Los Angeles on October 30, 2024. During the conference, Elutia management will also engage in individual meetings with institutional investors. The company specializes in drug-eluting biomatrix products aimed at enhancing the compatibility of medical devices for patients. This participation underscores Elutia's commitment to expanding its reach and connecting with potential investors.
Read more →ELUT▼ -6.1%on this news
Elutia Announces New Peer Reviewed Publication Highlighting the Robustness of EluPro™, Company’s Antibiotic-Eluting BioEnvelope for Implantable Devices
Elutia Inc. has published new preclinical data showcasing the effectiveness of EluPro, an antibiotic-eluting biologic envelope, in eradicating bacteria linked to cardiac implant infections. The product, which has received FDA clearance, was successful in an animal model, demonstrating significant bacterial reduction without systemic exposure. First human implantations of EluPro were completed in September, and the company is preparing for its commercial launch in January 2025, emphasizing its potential benefits in infection control for implantable devices.
Read more →ELUTElutia Celebrates First Year; Company Thanks Stakeholders and Employees for a Year of Remarkable Growth and Accomplishment
Elutia Inc. celebrates its first anniversary, marking significant achievements in its transition to drug-eluting biologics. The company secured FDA approval for its EluPro product and successfully implanted the first envelope. With a 20% increase in sales and a 170% rise in shareholder value, Elutia expresses gratitude to its stakeholders for their support.
Read more →ELUT▲ +5.4%on this newsshared move
Elutia Celebrates First Year
Elutia Inc. is celebrating its first anniversary after a significant year marked by various achievements. The company successfully pivoted toward drug-eluting biologics, securing FDA approval for its innovative EluPro product and growing sales by 20%. With a 170% increase in shareholder value and the first implantation of EluPro, Elutia has demonstrated remarkable growth and commitment to its mission. The leadership expressed gratitude to stakeholders and employees who contributed to the company's journey.
Read more →ELUTElutia Announces First Patient Implant of EluPro™, the World’s First Drug-Eluting BioEnvelope for Cardiac Pacemakers and Neurostimulators
Elutia Inc. has announced the first patient implant of EluPro, the world's first antibiotic-eluting biologic envelope for cardiac pacemakers and neurostimulators, marking a significant milestone validated by FDA clearance. The implant was conducted by Dr. John Catanzaro at East Carolina University Health Medical Center. This innovative solution is designed to prevent post-operative complications and improve patient outcomes, positioning Elutia within a lucrative $600 million market and a broader $8 billion cardiac rhythm management realm. Elutia aims for a full commercial launch in January 2025.
Read more →ELUTElutia Announces Second Quarter 2024 Results
Elutia Inc. announced its second quarter 2024 results, highlighting the FDA clearance for its antibiotic-eluting product, EluPro. The company has commenced manufacturing and received positive responses from potential partners and physicians. Financially, Elutia reported stable overall net sales, but a significant increase in net loss was attributed to a non-cash charge. Despite this, the company's solid funding position and commercial team expansions indicate proactive efforts for product launch and market presence.
Read more →ELUTElutia Announces Second Quarter 2024 Results Launch Production of EluPro Underway, Commercial Team Expansion Continues, Financial Position Solidified
Elutia Inc. has announced its second quarter 2024 results, highlighting the FDA clearance of EluPro, an antibiotic-eluting BioEnvelope. The company has begun manufacturing EluPro, which is expected to have a significant impact on the market for implantable electronic devices. Financially, Elutia reported a significant net loss of $28.2 million, partly due to a non-cash charge, although they have solidified their financial position with new capital. The commercial team is expanding to ensure the successful launch and growth of both EluPro and SimpliDerm products.
Read more →ELUT▼ -6.3%on this news· ran to -20% by day 3
Elutia Announces Full Exercise of Warrants Generating $15.7 Million in Gross Proceeds
Elutia Inc. announced the successful exercise of outstanding warrants, generating approximately $15.7 million in gross proceeds. This financial boost aims to strengthen the company’s balance sheet as it prepares to launch EluPro®, a pioneering FDA-cleared antibiotic-eluting BioEnvelope. The transaction, part of a previous private placement financing, involved the sale of shares and warrants not registered under the Securities Act, highlighting potential regulatory challenges. As Elutia continues to develop its drug-eluting biomatrix products, its future performance faces uncertainty from reliance on external investments and ongoing legal matters regarding past products.
Read more →ELUTElutia Appoints Ryan Marques, Ph.D., MBA as Vice President of Operations
Elutia Inc. has appointed Ryan Marques, Ph.D., MBA as its new Vice President of Operations. Dr. Marques brings over 20 years of experience in the pharmaceutical and medical device industries. His expertise will support Elutia's upcoming launch of EluPro, an FDA-cleared antibiotic-eluting BioEnvelope, aimed at improving patient outcomes. The company is focused on expanding production capacity and enhancing its drug-eluting biomatrix product offerings.
Read more →ELUTElutia to Report Second Quarter 2024 Financial Results on Wednesday, August 7, 2024
Elutia Inc. has announced it will report its second quarter 2024 financial results on August 7, 2024, after market close. The company's management team will host a conference call and webcast at 4:30 p.m. Eastern Time on the same day for investors. Elutia focuses on developing drug-eluting biomatrix products to enhance compatibility between medical devices and patients, addressing the needs of a growing population requiring implantable technologies.
Read more →ELUTElutia to Present at the Emerging Growth Conference on Thursday, July 18
Elutia Inc. (Nasdaq: ELUT) is set to present at the Emerging Growth Conference on July 18, 2024. Dr. Randy Mills, the company's CEO, will discuss the firm’s innovations in drug-eluting biomatrix products. Following the presentation, Elutia's management will hold one-on-one meetings with institutional investors, enhancing its engagement within the investment community. The conference aims to spotlight companies with significant growth potential across diverse sectors.
Read more →ELUT▼ -17%on this news
Elutia Announces FDA Clearance of EluPro™: The First Antibiotic-Eluting BioEnvelope Designed to Protect Patients with Implantable Cardiac Pacemakers and Defibrillators
Elutia Inc. has received FDA clearance for EluPro, the first antibiotic-eluting BioEnvelope designed to protect patients with implantable cardiac devices. This innovative product not only targets complications associated with pacemakers and defibrillators but also extends its indications to neurostimulators and neuromodulators. EluPro aims to enhance patient safety and reduce healthcare costs linked to device-related infections.
Read more →ELUT▼ -17%on this newsshared move
Elutia Announces $13.26 Million Registered Direct Offering
Elutia Inc. announced a definitive agreement to raise approximately $13.26 million through a registered direct offering. The offering includes the sale of 3,175,000 shares of Class A common stock and prefunded warrants. The funds are intended for working capital and general corporate purposes, with the closing expected on June 18, 2024. Street Capital Markets is acting as the exclusive placement agent for this offering. Elutia focuses on developing drug-eluting biomatrix products for improved medical device compatibility.
Read more →ELUT▼ -17%on this newsshared move
Elutia Announces FDA Clearance of EluPro : The First Antibiotic-Eluting BioEnvelope Designed to Protect Patients with Implantable Cardiac Pacemakers and Defibrillators EluPro becomes the only drug-eluting biologic envelo
Elutia has received FDA clearance for EluPro, an antibiotic-eluting BioEnvelope designed to protect patients with implantable cardiac devices. This product is the first of its kind to enter the $600 million U.S. implantable electronic device protection market and also extends its indications to neurostimulators and neuromodulators. EluPro aims to minimize risks associated with complications from surgeries, such as infections and device migrations. With a launch planned for the second half of 2024, EluPro holds promise in addressing significant medical needs in implantable technology.
Read more →ELUTElutia to Showcase BioEnvelope Product Line at Heart Rhythm 2024
Elutia Inc. will showcase its CanGaroo BioEnvelope product line at the Heart Rhythm Society's annual meeting (HRS 2024) from May 16-18, 2024, in Boston. The CanGaroo BioEnvelope is designed for cardiac implantable electronic devices and aims to enhance patient comfort while minimizing inflammation and promoting tissue health. Its acellular biologic matrix has been clinically proven to reduce complications post-implantation. Elutia's participation at HRS 2024 is an opportunity to demonstrate their innovative technologies in cardiac device protection.
Read more →ELUT▲ +17.5%on this newsshared move
Elutia Announces First Quarter 2024 Results: SimpliDerm® Sales Increase 55%, CanGaroo®RM on Track for Second Quarter 2024 FDA Clearance
Elutia Inc. reported a strong first quarter for 2024, with SimpliDerm sales rising 55% year-over-year. The company anticipates FDA clearance for its CanGarooRM product by the end of June 2024, which is expected to disrupt the pacemaker protection market. However, Elutia also reported an increased net loss and a decline in cardiovascular product sales.
Read more →ELUTElutia Announces First Quarter 2024 Results: SimpliDerm Sales Increase 55%, CanGaroo RM on Track for Second Quarter 2024 FDA Clearance
Elutia Inc. reported strong financial results for the first quarter of 2024, highlighted by a 55% increase in sales of its SimpliDerm product. The company is preparing for the expected FDA clearance of its CanGaroo RM product in the second quarter, which targets the pacemaker and implantable defibrillator protection market. Elutia's innovative approach aims to capture a significant share of a market currently dominated by a single competitor.
Read more →ELUTElutia to Report First Quarter 2024 Financial Results on Thursday, May 9, 2024
Elutia Inc. has announced it will release its first quarter 2024 financial results after market close on May 9, 2024. A conference call and webcast will follow the release, offering insights from the management team. Elutia specializes in drug-eluting biomatrix products aimed at enhancing the compatibility of medical devices with patients.
Read more →ELUTElutia to Present at the Planet MicroCap Showcase: VEGAS 2024 on Wednesday, May 1
Elutia Inc. is scheduled to present at the Planet MicroCap Showcase: VEGAS 2024 on May 1, 2024. Dr. Randy Mills, the CEO, and CFO Matt Ferguson will lead the presentation. Additionally, the Elutia management team will engage in one-on-one investor meetings on May 2, 2024, enhancing their outreach to potential investors. The company focuses on developing biologic products to improve the compatibility of medical devices with patients.
Read more →ELUTElutia Reports Fourth Quarter and Full Year 2023 Financial Results: Anticipates CanGarooRM Clearance Decision in First Half of 2024
Elutia Inc. reported its fourth quarter and full year 2023 financial results, emphasizing progress towards FDA clearance for its flagship product, CanGarooRM, anticipated in the first half of 2024. CEO Dr. Randy Mills highlighted the positive interactions with the FDA during the submission process, which completed successfully with limited clarification requests. Elutia's sales performance has been strong, positioning the company favorably in the competitive drug-eluting envelope market. The company is actively preparing for a coordinated product launch to optimize CanGarooRM's market entry.
Read more →ELUT▼ -9.2%on this news
Elutia to Report Fourth Quarter and Full Year 2023 Financial Results on Thursday, March 7, 2024
Elutia Inc. has announced that it will report its financial results for the fourth quarter and full year 2023 on March 7, 2024, after market close. A conference call and webcast will follow at 4:30 p.m. ET for investors to discuss the results. The company, known for its drug-eluting biomatrix products, emphasizes its commitment to advancing medical technology and improving patient care. Access details for the conference call have been provided to both U.S. and international investors.
Read more →ELUTElutia Submits CanGarooRM Antibiotic-Eluting Biomatrix for FDA Clearance
Elutia Inc. has submitted a 510(k) premarket notification to the FDA for its antibiotic-eluting biomatrix, CanGarooRM, designed for use with cardiac implantable electronic devices. The submission follows positive feedback from the FDA's pre-submission meeting, and the company is preparing for a commercial launch anticipated in early 2024. CanGarooRM aims to reduce infection rates linked to pacemaker implantation, enhancing patient outcomes in a significant market opportunity currently dominated by one competitor. Elutia positions this product as potentially transformative for both its business and patient care in the cardiovascular space.
Read more →ELUTManagement's Discussion and Analysis of Financial Condition and Results of Operations with Retrospective Segment Changes of the 2022 Form 10-K. The following discussion and analysis should be read in conjunction with our
Elutia's recent management discussion reflects on its financial condition, focusing on the divestiture of its Orthobiologics Business segment, which was sold on November 8, 2023. This sale has resulted in a reclassification of operations, impacting the company's financial reporting. Despite promising market growth in sectors like Device Protection and Women's Health, Elutia continues to face significant operating losses and uncertainty regarding future profitability. The company anticipates ongoing expenses while also exploring potential capital-raising options to address liquidity concerns.
Read more →ELUT▲ +11.6%on this news
Elutia Reports 26% Year-Over-Year Sales Growth of Proprietary Products and Strengthened Balance Sheet in Third Quarter 2023 Financial Results
Elutia Inc. reported a 26% increase in year-over-year sales for its proprietary products in Q3 2023, highlighting strong performance from SimpliDerm and CanGaroo. The company anticipates filing a 510(k) for CanGarooRM by year-end after a productive FDA meeting. Financially, Elutia has strengthened its balance sheet through a business divestiture and private placement, although it continues to report net losses.
Read more →ELUTElutia Reports 26% Year-Over-Year Sales Growth of Proprietary Products and Strengthened Balance Sheet in Third Quarter 2023 Financial Results - Anticipate 510(k) filing for transformational Drug-Eluting Biomatrix CanGaro
Elutia Inc. reported a robust 26% year-over-year sales growth of its proprietary products in the third quarter of 2023, bolstered by strong performance from CanGaroo and SimpliDerm. The company is preparing for a pivotal FDA 510(k) filing for its CanGarooRM biomatrix product, anticipated by year-end. Despite these positive developments, Elutia continues to face financial challenges with a net loss of $8.5 million from continuing operations and a decline in gross margins due to changes in their distribution strategy. Overall, the company aims to leverage recent capital inflow from a private placement and the divestiture of its Orthobiologics business to stabilize its operations.
Read more →ELUT▼ -10.4%on this newsshared move
Elutia Completes Divestiture of Orthobiologics Business Unit for Cash Proceeds of Up to $35 Million
Elutia Inc. has successfully divested its Orthobiologics business unit to Berkeley Biologics LLC, securing cash proceeds of up to $35 million. This strategic move allows Elutia to concentrate on its proprietary drug-eluting biomatrix platform, particularly the CanGaroo®RM product. The company anticipates that the funds will support its growth and development efforts in the biomatrix sector.
Read more →ELUT▼ -10.4%on this newsshared move
Elutia Completes Divestiture of Orthobiologics Business Unit for Cash Proceeds of Up to $35 Million - Company Now Focused on Proprietary Drug-Eluting Biomatrix Platform
Elutia Inc. has completed the divestiture of its Orthobiologics business unit, receiving up to $35 million in cash proceeds. This strategic move allows Elutia to concentrate on its proprietary drug-eluting biomatrix platform, which includes the potential blockbuster product CanGaroo RM. The divestiture, coupled with a recent private placement, positions the company to advance its core technologies. However, there are noted risks associated with the transition and financial performance, as well as dependency on commercial partners.
Read more →ELUT▲ +13.1%on this newsshared move
UNAUDITED PRO FORMA CONDENSED CONSOLIDATED FINANCIAL STATEMENTS On
On November 8, 2023, Elutia Inc. finalized the sale of its Orthobiologics segment to Berkeley Biologics, structured as an asset purchase. This move will result in the elimination of Orthobiologics from Elutia's consolidated financial statements. The company has provided unaudited pro forma consolidated financial information to reflect the potential impact of the sale, which includes significant financial losses. The adjustments illustrate the company's intent for a streamlined focus following the divestiture, though actual future performance remains uncertain.
Read more →ELUTElutia to Report Third Quarter 2023 Financial Results on Monday, November 13, 2023
Elutia Inc. has announced that it will release its third quarter 2023 financial results on November 13, 2023, after the market closes. A conference call and webcast will be held at 4:30 p.m. ET, allowing investors to participate and access the results. The company is noted for its development of biologic products that enhance compatibility between medical devices and patients, which is particularly relevant given the increasing demand for implantable technologies.
Read more →ELUTElutia to Participate in a Panel Discussion at the Cantor Global Healthcare Conference
Elutia Inc. announced its participation in the Cantor Global Healthcare Conference, where Dr. Randy Mills will engage in a panel discussion. The event is scheduled for September 27, 2023, in New York. Institutional investors have the chance to connect with management, enhancing investor relations during the conference. The company focuses on developing biologic products to improve the compatibility of medical devices.
Read more →ELUTElutia Announces Private Placement for Proceeds Up to $26 Million
Elutia Inc. has announced a private placement financing expected to generate approximately $10.5 million, with potential total proceeds of $26.2 million. This funding, along with the recent divestiture of its Orthobiologics business, could enhance Elutia's financial position significantly. The company aims to advance its drug-eluting biomatrix products for cardiac and breast reconstruction applications.
Read more →ELUT▲ +33.1%on this newsshared move
Elutia Announces Private Placement for Proceeds Up to $26 Million - Combined proceeds of financing and Orthobiologics divestiture potentially top $60 million
Elutia Inc. has announced a private placement financing, estimating initial gross proceeds of about $10.5 million, with potential total gross proceeds of $26.2 million. The funds, combined with a divestiture of its Orthobiologics business, could provide more than $60 million to enhance its financial standing. This capital will support its advancements in drug-eluting biomatrix products aimed at cardiac pacemakers, defibrillators, and breast reconstruction. The financial backing reflects investor confidence in Elutia's technology and its strategic focus on these therapeutic areas.
Read more →ELUT▲ +33.1%on this newsshared move
Elutia Announces Sale of Orthobiologics Business Unit for Cash Proceeds of Up to $35 Million
Elutia Inc. has announced the sale of its Orthobiologics business unit to Berkeley Biologics LLC for cash proceeds of up to $35 million. This strategic move allows Elutia to focus on its proprietary drug-eluting biomatrix platform, particularly the upcoming CanGaroo RM product, expected to launch in early 2024. The transaction is anticipated to close in Q4 2023.
Read more →ELUT▲ +9.7%on this news· ran to +46% by day 1shared move
Elutia Announces Sale of Orthobiologics Business Unit for Cash Proceeds of Up to $35 Million - Transaction Reflects Increasing Strategic Focus on Proprietary Drug-Eluting Biomatrix Platform
Elutia Inc. has announced the sale of its Orthobiologics business unit to Berkeley Biologics LLC for cash proceeds of up to $35 million. The transaction, which includes an upfront payment of $15 million and potential earnouts of up to $20 million, is expected to close in Q4 2023. This divestiture allows Elutia to concentrate on its proprietary drug-eluting biomatrix technology, including the upcoming CanGaroo RM product, which targets a large market for improved surgical outcomes. The company aims to launch CanGaroo RM in the first half of 2024.
Read more →ELUT▼ -7.3%on this news· ran to -21% by day 3
Elutia to Present at the H.C. Wainwright 25th Annual Global Investment Conference
Elutia Inc. (Nasdaq: ELUT) announced that its CEO, Dr. Randy Mills, will present at the H.C. Wainwright 25th Annual Global Investment Conference on September 13, 2023, in New York. The event is aimed at institutional investors, and a live webcast will be available. Elutia focuses on developing biologic products aimed at enhancing the compatibility of medical devices for patients. The company's vision is to humanize medicine, catering to the growing demand for implantable technologies.
Read more →ELUTAziyo Biologics Rebrands as Elutia to Reflect Strategic Focus on Drug Eluting Biomatrices
Aziyo Biologics has rebranded as Elutia to emphasize its commitment to developing drug-eluting biomatrix technology. The company will begin trading under the new ticker symbol 'ELUT' on September 7, 2023. Elutia's first product will target the pacemaker and implantable defibrillator markets, with plans for further expansion into neurostimulator markets. The rebranding reflects a strategic shift aimed at improving surgical outcomes.
Read more →ELUTAziyo Biologics Rebrands as Elutia to Reflect Strategic Focus on Drug Eluting Biomatrices - Company to begin trading under new ticker symbol "ELUT"
Aziyo Biologics has officially rebranded to Elutia, effective September 6, 2023. This change reflects the company's strategic pivot towards developing drug-eluting biomatrix technologies primarily aimed at improving surgical outcomes. Elutia's first anticipated product targets the pacemaker and implantable defibrillator markets. In addition, the company is set to expand its offerings in the neurostimulator markets while addressing unmet medical needs in breast reconstruction procedures.
Read more →ELUTAziyo Biologics Reports Second Quarter 2023 Financial Results - Transformation Continues to Drug-Eluting Biomatrix Company Negotiating multiple LOIs to divest Orthopedic business CanGaroo RM 510(k) resubmission to the FD
Aziyo Biologics reported its second quarter 2023 financial results, showing a 32% increase in quarterly net sales year-over-year, primarily driven by strong performance in the SimpliDerm product line. However, the company faced challenges with a recall of its viable bone matrix products, which led to a significant decline in gross margin and increased net losses. Aziyo is currently negotiating multiple letters of intent to divest its Orthopedic business and is on track with its CanGaroo RM 510(k) resubmission to the FDA. Overall, the company is pursuing a transformation towards a drug-eluting biomatrix focus amidst various operational challenges.
Read more →ELUTAziyo Biologics Announces Voluntary Recall of Viable Bone Matrix Products
Aziyo Biologics has announced a voluntary recall of its viable bone matrix products due to reported post-surgical Mycobacterium tuberculosis infections in two patients. The infections were linked to a specific donor lot that had tested negative for MTB prior to release. In response to this serious issue, Aziyo has suspended shipments of all viable bone matrix products and is actively working with the CDC and FDA to investigate and notify affected physicians. The company's swift action aims to ensure patient safety amidst these concerning developments.
Read more →ELUTAziyo Biologics Reports Highest Sales and Gross Profit in Company History - All Four Business Segments Achieved Growth Led by Strong SimpliDerm and CanGaroo Sales
Aziyo Biologics, Inc. reported a record net sales of $13.1 million and gross profit of $6.3 million for the first quarter of 2023, representing a 14% growth year-over-year. All four business segments achieved growth, particularly with SimpliDerm and CanGaroo products. The company is also executing plans for FDA clearance of CanGaroo RM and has established partnerships to expand its cardiovascular and SimpliDerm product line reach. Despite a modest net loss of $8.0 million, improvements in gross margin indicate enhanced operational efficiency.
Read more →ELUTAziyo Biologics and LeMaitre Vascular Partner for the Distribution of Aziyo's Cardiovascular Portfolio
Aziyo Biologics has signed a distribution agreement with LeMaitre Vascular for its cardiovascular product line. This partnership grants LeMaitre exclusive U.S. distribution rights for selected Aziyo products, including ProxiCor PC and Tyke. The collaboration aims to leverage LeMaitre's commercial strength, enhancing operational efficiency for Aziyo while focusing on their flagship CanGaroo Envelope. The agreement includes an option for LeMaitre to acquire the product line after the first year.
Read more →ELUTAziyo Biologics Reports Record Full Year 2022 Revenues
Aziyo Biologics, Inc. reported record revenues for the fiscal year 2022, helping over 50,000 patients with its products. The company achieved a 16% increase in net sales for current products, although it faced challenges, including FDA delays on market clearance for its CanGaroo RM Antibacterial Envelope. Operating expenses rose significantly, contributing to a net loss of $32.9 million, compared to $24.8 million in the prior year. In response, Aziyo plans to implement measures to extend its cash runway and adjust its business model for greater capital efficiency.
Read more →ELUTAziyo Biologics Provides Update on FDA Submission for CanGaroo RM Antibacterial Envelope
Aziyo Biologics has provided an update concerning its FDA submission for the CanGaroo RM Antibacterial Envelope, which is designed to hold cardiac implantable devices securely. The FDA issued a Not Substantially Equivalent determination regarding the submission, indicating that additional data is required, particularly about drug testing. Despite the delay, Aziyo's leadership remains optimistic about addressing the FDA's requests and moving forward. A conference call will be held to discuss the company's financial results and future steps.
Read more →ELUTAziyo Biologics Announces Record Annual Net Sales in Preliminary (Unaudited) Fourth Quarter and Full Year 2022 Topline Results
Aziyo Biologics reported record annual net sales for 2022 in its preliminary results. The company highlighted a 30% anticipated growth in its SimpliDerm and CanGaroo product lines during the fourth quarter. With successful financing raising $15.2 million, Aziyo is positioning itself for future growth, including the introduction of new products pending FDA approval. The final full-year results will be reported in early March 2023, subject to the completion of year-end accounting procedures.
Read more →ELUTAziyo Biologics Reports Strong Third Quarter 2022 Revenue Positive meeting with FDA provides clarity for CanGaroo RM clearance
Biologics Reports Strong Third Quarter 2022 Revenue with FDA provides clarity for CanGaroo RM clearance SILVER SPRING, Md., November 14, 2022 (GLOBE NEWSWIRE) - Aziyo Biologics, Inc. (Nasdaq: AZYO), a biologics company with a portfolio of regenerative products aimed at improvi
Read more →ELUTAziyo Biologics Appoints Seasoned Healthcare Executive, David Colpman, to Board of Directors Industry veteran brings more than 25 years of healthcare business development and transaction experience
Biologics Appoints Seasoned Healthcare Executive, David Colpman, to Board of Directors veteran brings more than 25 years of healthcare business development and transaction experience SPRING, Md., October 24, 2022 (GLOBE NEWSWIRE) -- Aziyo Biologics, Inc. (Nasdaq: AZYO), a regen
Read more →ELUTAZIYO BIOLOGICS, INC. INDEX TO FINANCIAL STATEMENTS Report of Independent Registered Public Accounting Firm (PCAOB ID: 238) F-2 ​ ​ Consolidated Balance Sheets F-3 ​ ​ Consolidated Statements
10444767285254110444767285254192451467091960431340631341622.388.88P7YP3YP10Y3400000340000034000003400000340000034000000.07172.382.388.88 AZIYO BIOLOGICS, INC. INDEX TO FINANCIAL STATEMENTS Report of Independent Registered Public Accounting Firm (PCAOB ID: 238) F-2 Consolidated
Read more →ELUTAziyo Biologics Announces Second Quarter 2022 Financial Results and Recent Business Achievements, Including Robust Revenue Growth and Strengthened Balance Sheet
Aziyo Biologics Announces Second Quarter 2022 Financial Results and Recent Business Achievements, Including Robust Revenue Growth and Strengthened Balance Sheet SILVER SPRING, Md. - August 11, 2022 - Aziyo Biologics, Inc. (Nasdaq: AZYO), a commercial-stage regenerative medicin
Read more →ELUTAziyo Biologics Provides Business Update and Reports First Quarter 2022 Financial Results
Aziyo Biologics Provides Business Update and Reports First Quarter 2022 Financial Results SILVER SPRING, Md. - May 9, 2022 - Aziyo Biologics, Inc. (Nasdaq: AZYO), a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products
Read more →ELUTAZY0 Q4 2021 Earnings Press Release Aziyo Biologics Reports Fourth Quarter and Full Year 2021 Financial Results
Aziyo Biologics Reports Fourth Quarter and Full Year 2021 Financial Results SILVER SPRING, Md. - March 3, 2022 - Aziyo Biologics, Inc. (Nasdaq: AZYO), a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and improvin
Read more →ELUTAziyo Biologics Announces $14.0 Million Private Placement Silver Spring, MD
Aziyo Biologics Announces $14.0 Million Private Spring, MD, December 6, 2021 - Aziyo Biologics, Inc. (the "Company") today announced that it has entered into a definitive agreement to sell securities in a private placement that is expected to result in gross proceeds to the Com
Read more →ELUTAziyo Biologics Reports Third Quarter 2021 Financial Results
Aziyo Biologics Reports Third Quarter 2021 Financial Results SILVER SPRING, Md. - November 9, 2021 - Aziyo Biologics, Inc. (Nasdaq: AZYO), a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and improving outcomes i
Read more →ELUTAziyo Biologics Provides Business Update and Preliminary Third Quarter 2021 Revenue Results and Announces Timing for Third Quarter 2021 Financial Results
Provides Business Update and Preliminary Third Quarter 2021 Revenue Results and Announces Timing for Third Quarter 2021 Financial Results SILVER SPRING, Md. - October 25, 2021 - Aziyo Biologics, Inc. (Nasdaq: AZYO), a commercial-stage regenerative medicine company focused on cr
Read more →ELUTAziyo Biologics Reports Second Quarter 2021 Financial Results
Aziyo Biologics Reports Second Quarter 2021 SILVER SPRING, Md. - August 9, 2021 - Aziyo Biologics, Inc. (Nasdaq: AZYO), a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and improving outcomes in patients underg
Read more →ELUTAziyo Biologics Comments on June 2nd
Aziyo Biologics Comments on June 2nd Voluntary Recall of One Lot of its FiberCel Fiber Viable Bone Matrix SILVER SPRING, Md. - June 7, 2021 - Aziyo Biologics, Inc. (Nasdaq: AZYO) on June 2, 2021 issued a voluntary recall pertaining to a single donor lot of its FiberCel Fiber V
Read more →ELUTAziyo Biologics Reports First Quarter 2021 Financial Results and Increases 2021 Revenue Guidance
Aziyo Biologics Reports First Quarter 2021 Financial Results and Increases 2021 Revenue Guidance SILVER SPRING, Md. - May 4, 2021 - Aziyo Biologics, Inc. (Nasdaq: AZYO), a commercial-stage regenerative medicine company focused on creating the next generation of differentiated
Read more →ELUTAziyo Biologics Reports Fourth Quarter and Full Year 2020 Financial Results
Aziyo Biologics Reports Fourth Quarter and Full Year 2020 Financial Results SILVER SPRING, Md. - March 1, 2021 - Aziyo Biologics, Inc. (Nasdaq: AZYO), a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and impro
Read more →ELUTAziyo Biologics Reports Third Quarter 2020 Financial Results
Aziyo Biologics Reports Third Quarter 2020 Financial Results SILVER SPRING, Md. - November 19, 2020 - Aziyo Biologics, Inc. (Nasdaq: AZYO), a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and improving outcom
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