| 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
Orchestra BioMed Holdings, Inc.$3.99
+0.07 (+1.79%)
F 16Pipeline Score MedTech · Commercial
Market Cap
243.12 M
EPS
-1.13
P/E Ratio
-
Value Trade
924.50 K
SEC Financials
Q1 2026Dilution Risk
40%Revenue
110.00 K
R&D Expenses
15.78 M
Operating CF
-22.17 M
Total Assets
100.66 M
Total Liabilities
49.69 M
Equity
41.19 M
D/E Ratio
12,345
0.74 %
Week
-5.8 %
1 Month
3.57 %
3 Month
-9.38 %
6 Month
-60 %
5 Year
-64.42 %
All Time
Cash Data
Cash Position
94.40 M
Monthly Burn
7.39 M
Runway
11.1 mo
Burn Trend
SEC Filing
May 12, 2026
Overview
Volume
161.46 K
52 Week Range
2.20 - 5.42
% held by Insiders
31.09 %
% held by Institutions
40.66 %
Enterprise Value
192.12 M
Total Shares
59.89 M
Short %
7.48 %
Float Shares
29.71 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Orchestra BioMed Holdings, Inc.
1Total events
0Upcoming
0Tier-1 (high impact)
2026 – 2026Coverage
Event history 1
Drug Pipeline Intelligence
F16
Pipeline Score -
Pipeline ValueValuation Signal
0
Drugs Scored—
rNPV / MCap Top 13%
Micro Cap (rank 794 of 911)
Percentile RankOrchestra BioMed Holdings, Inc. has significant pipeline risk (16/100).
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
AVIM Therapy Breakthrough | Hypertensive Heart Disease | — | 2026-04-23 | 13.2 mmHg; 97%; 125.2 mmHg; 89%; 58% | Orchestra BioMed to Present AVIM Therapy Clinical and Mechanistic Data at HRS 2026 Read More | |
AVIM Therapy Breakthrough | Hypertensive Heart Disease | — | 2026-04-23 | 13.2 mmHg; 97%; 125.2 mmHg; 89%; 58% | Orchestra BioMed to Present AVIM Therapy Clinical and Mechanistic Data at HRS 2026 Read More | |
AVIM Therapy Breakthrough | Hypertensive Heart Disease | — | 2026-04-23 | 13.2 mmHg; 97%; 125.2 mmHg; 89%; 58% | Orchestra BioMed to Present AVIM Therapy Clinical and Mechanistic Data at HRS 2026 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 OBIO
| 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 |
OBIO 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 | |
| 2027-02-19 | 0.00 | 0 | - | - | - | - | - | - | ||||
| 2027-02-19 | 0.00 | 0 | - | - | - | - | - | - | ||||
| 2027-02-19 | 0.00 | 0 | - | - | - | - | - | - | ||||
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
OBIO▲ +12%on this news
Orchestra BioMed Joins Russell 3000® and Russell 2000® Indexes
Orchestra BioMed Holdings, Inc. has announced its inclusion in the Russell 3000 and Russell 2000 indexes following the 2026 reconstitution. This membership is significant as it enhances the company's visibility among investors and aligns it with a broad range of market capitalizations. The company is known for its innovative biomedical technologies, including therapies for hypertension and atherosclerotic artery disease.
Read more →OBIOOrchestra BioMed Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - June 2, 2026
Orchestra BioMed announced the grant of stock options to five new employees as part of its 2025 New Hire Inducement Plan, in compliance with Nasdaq Listing Rule 5635(c)(4). The company is focused on advancing its flagship product candidates, AVIM Therapy and Virtue SAB, which are in pivotal clinical trials and target significant market opportunities in hypertension and atherosclerotic artery disease.
Read more →OBIOOrchestra BioMed Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Orchestra BioMed announced the granting of stock options to five new employees as part of its 2025 New Hire Inducement Plan, in compliance with Nasdaq Listing Rule 5635(c)(4). This move reflects the company's commitment to growth and innovation in biomedical technologies. The company is also advancing two key product candidates that target major health issues, supported by strategic partnerships.
Read more →OBIOOrchestra BioMed to Participate in the Jefferies Global Healthcare Conference
Orchestra BioMed Holdings, Inc. announced its participation in the Jefferies Global Healthcare Conference. CEO David Hochman will engage in a fireside chat and hold one-on-one meetings with investors. The event highlights the company's innovative therapies, including AVIM Therapy and Virtue SAB, both of which have received FDA Breakthrough Device Designations.
Read more →OBIOOrchestra BioMed Reports First Quarter 2026 Financial Results and Highlights Recent Business Updates
Orchestra BioMed reported its Q1 2026 financial results, highlighting advancements in its BACKBEAT Trial and AVIM Therapy. The company aims to complete enrollment by Q3 2026 and plans a late-breaking presentation at a major cardiology conference in Q2 2027. The FDA granted a second Breakthrough Device Designation for AVIM Therapy, enhancing its market potential. Despite a net loss increase, the company maintains a strong cash runway through Q4 2027.
Read more →OBIOOrchestra BioMed Targeting BACKBEAT Trial Enrollment Completion By End of Q3 2026 and Data Presentation in Q2 2027
Orchestra BioMed aims to complete enrollment for the BACKBEAT Trial by Q3 2026, evaluating AVIM Therapy for hypertension in pacemaker patients. The company plans to present primary endpoint results at a major cardiology conference in Q2 2027. Medtronic will seek FDA approval for AVIM Therapy following successful data analysis.
Read more →OBIOOrchestra BioMed Receives $20 Million Payment from Medtronic Under Previously Announced Financing Agreement
Orchestra BioMed has received a $20 million payment from Medtronic as part of a strategic financing agreement. This funding will support the BACKBEAT Trial, which evaluates Atrioventricular Interval Modulation Therapy for patients with uncontrolled hypertension. The investment reflects Medtronic's commitment to advancing this innovative treatment, which has received FDA Breakthrough Device Designation.
Read more →OBIOOrchestra BioMed Receives $15 Million Investment from Ligand Under Previously Announced Strategic Financing Agreement
Orchestra BioMed has received a $15 million investment from Ligand Pharmaceuticals, completing a scheduled tranche under a royalty-based financing agreement. This investment brings the total capital from Ligand to $40 million, aimed at supporting pivotal trials for its AVIM Therapy and Virtue SAB. The funding reflects confidence in the potential of these therapies to address significant unmet medical needs in cardiovascular health.
Read more →OBIO▲ +5%on this news
FDA Grants Orchestra BioMed Additional Breakthrough Device Designation for AVIM Therapy
Orchestra BioMed has received a second Breakthrough Device Designation from the FDA for its Atrioventricular Interval Modulation (AVIM) Therapy, targeting patients with uncontrolled hypertension. This designation covers a broad patient population and supports favorable reimbursement pathways. The therapy is being evaluated in the BACKBEAT Trial, conducted in collaboration with Medtronic, aiming to improve patient outcomes in hypertension management.
Read more →OBIOOrchestra BioMed to Present AVIM Therapy Clinical and Mechanistic Data at HRS 2026
Orchestra BioMed announced that it will present new clinical and mechanistic data on its AVIM Therapy at the HRS 2026 Annual Meeting. The data from the MODERATO II trial showcase significant reductions in office systolic blood pressure among patients. AVIM Therapy showed an immediate average reduction of 13.2 mmHg, with 97% of patients achieving significant blood pressure reductions. The company is also actively enrolling patients for the BACKBEAT Global Pivotal Trial to further evaluate AVIM Therapy's efficacy.
Read more →OBIOOrchestra BioMed Reports Full Year 2025 Financial Results and Provides Fourth Quarter Business Update
Orchestra BioMed reported a strong financial performance for 2025, with revenues soaring to $33.5 million, driven by strategic partnerships and agreements. The company is well-positioned for future growth with a cash position of $106.5 million and ongoing pivotal trials for its AVIM Therapy and Virtue SAB programs. CEO David Hochman highlighted the successful enrollment in these trials and the positive impact of recent transactions with Medtronic and Terumo.
Read more →OBIOOrchestra BioMed Announces Presentations Highlighting AVIM Therapy Potential Impact on Hypertensive Heart Disease and Heart Failure at THT and CRT
Orchestra BioMed announced presentations at THT and CRT 2026, showcasing their Atrioventricular Interval Modulation Therapy (AVIM Therapy) for hypertensive heart disease and heart failure. Presenters highlighted clinical data demonstrating significant reductions in systolic blood pressure and improvements in cardiac function. The therapy is positioned as a novel treatment option for patients with limited alternatives.
Read more →OBIOOrchestra BioMed to Participate in Upcoming Institutional Investor Conferences
Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) is set to participate in multiple upcoming institutional investor conferences. The company will engage in live fireside chats and one-on-one meetings at the TD Cowen 46th Annual Health Care Conference and Barclays 28th Annual Global Healthcare Conference. These events will allow Orchestra BioMed to connect with investors and enhance visibility within the industry through live webcasts.
Read more →OBIO▼ -8.2%on this news
Orchestra BioMed to Receive Up to $21 Million in Proceeds from Acquisition of Vivasure by Haemonetics
Orchestra BioMed announced it expects to receive up to $21 million from the acquisition of Vivasure by Haemonetics, which closed on January 9, 2026. The proceeds include an upfront payment and milestone payments based on future performance. Vivasure's PerQseal Elite system has demonstrated strong clinical results, positioning it as a leading solution for vessel closure.
Read more →OBIOOrchestra BioMed Announces AVIM Therapy and Virtue SAB Program Presentations at ICI Meeting
Orchestra BioMed announced three presentations at the 2025 ICI meeting in Tel Aviv, focusing on AVIM Therapy and Virtue SAB. The AVIM Therapy presentations will discuss its collaboration with Medtronic and its potential benefits for hypertensive heart disease. The Virtue SAB presentation will highlight its novel drug delivery system for treating coronary artery disease.
Read more →OBIO▼ -5.4%on this news
Orchestra BioMed Third Quarter 2025 Corporate Update Conference Call 12 November 2025 C O R P O R A T E P A R T I C I P A N T S Kelsey Kirk-Ellis, Director, Corporate Communications David Hochman, Chairman, Chief Executi
Orchestra BioMed held its Third Quarter 2025 Corporate Update Conference Call, led by CEO David Hochman. The company reported significant achievements, including raising nearly $150 million, enhancing its collaboration with Medtronic, and receiving FDA Breakthrough Device Designation for its AVIM Therapy. The pivotal IDE trials for both its AVIM Therapy and Virtue SAB are actively enrolling patients. The call emphasized Orchestra BioMed's strategic partnership model aimed at accelerating innovative medical device solutions.
Read more →OBIO▲ +8.5%on this newsshared move
Orchestra BioMed Reports Third Quarter 2025 Financial Results and Highlights Recent Business Updates
Orchestra BioMed Holdings, Inc. reported strong financial results for Q3 2025, securing nearly $150 million in capital. The company is advancing its pivotal-stage programs, AVIM Therapy and Virtue SAB, with enrollment actively underway in their registrational trials. CEO David Hochman expressed optimism for 2026, highlighting significant collaborations and favorable funding terms.
Read more →OBIOOrchestra BioMed to Host Business Update Call on November 12, 2025
Orchestra BioMed Holdings, Inc. announced a business update call scheduled for November 12, 2025. The call will cover recent strategic investments and collaborations, including partnerships with Medtronic and Ligand. The company is also advancing its pivotal clinical trials for AVIM Therapy and Virtue SAB, both of which have significant market potential.
Read more →OBIO▲ +11.1%on this newsshared move
Orchestra BioMed Corporate Overview October 2025 Nasdaq: OBIO Forward-Looking Statements This presentation has been prepared for informational purposes only from information supplied by Orchestra BioMed Holdings, Inc., r
Orchestra BioMed is preparing for the Virtue Trial, a pivotal study to evaluate the effectiveness of its Sirolimus AngioInfusion Balloon (SAB) in treating coronary in-stent restenosis. This trial aims to secure regulatory approval and showcases the differentiating factors of the product over existing options. The company has established significant partnerships, most notably with Terumo, which allows for potential strategic collaborations in the global coronary market. Promising safety and efficacy results from initial trials add optimism to the future success of the Virtue SAB.
Read more →OBIOOrchestra BioMed and Terumo Enter into New $30 Million Virtue SAB Strategic Agreements
Orchestra BioMed has entered into a new $30 million strategic partnership with Terumo Corporation, which includes a right of first refusal agreement regarding the Virtue Sirolimus AngioInfusion Balloon for treating coronary artery disease. This agreement replaces a prior distribution agreement and provides Terumo with the opportunity to acquire rights to Virtue SAB. The partnership is expected to close by November 7, 2025.
Read more →OBIOOrchestra BioMed Announces First Patients Enrolled in Virtue® SAB US Pivotal IDE Coronary Trial
Orchestra BioMed has announced the enrollment of the first patients in its U.S. pivotal IDE trial for the Virtue® Sirolimus AngioInfusionTMBalloon, aimed at treating coronary in-stent restenosis (ISR). This trial will compare the performance of Virtue SAB against the AGENT paclitaxel-coated balloon, with a total of 740 patients expected to be enrolled across 75 centers. The Virtue Trial is designed to support regulatory approval and has received FDA Breakthrough Device Designation.
Read more →OBIOOrchestra BioMed to Showcase Transformative Potential of AVIM Therapy in Keynote Presentation on Hypertensive Heart Disease at Georgia Innovation Summit
Orchestra BioMed announced that it will present data on Atrioventricular Interval Modulation (AVIM) Therapy at the Georgia Innovation Summit. The therapy aims to manage hypertensive heart disease and has shown potential in clinical studies to improve blood pressure and cardiac function. Dr. Avi Fischer will deliver the keynote presentation, emphasizing the therapy's transformative potential in hypertension care.
Read more →OBIOOrchestra BioMed Presents New AVIM Therapy Clinical Data at HRX Demonstrating Substantial and Sustained Blood Pressure Reductions that are Reproducible Upon Reactivation Following Washout
Orchestra BioMed has presented new clinical data on its AVIM therapy at the HRX Live 2025 Meeting, demonstrating significant and sustained reductions in blood pressure. The therapy's effects are reversible and reproducible upon reactivation, with no evidence of rebound hypertension. These findings support its potential as a durable treatment for uncontrolled hypertension, which is crucial for millions of patients globally.
Read more →OBIO▲ +15.4%on this news
Orchestra BioMed Announces Publication of Clinical Data Demonstrating Favorable Blood Pressure and Hemodynamic Effects of AVIM Therapy in JACC: Clinical Electrophysiology
Orchestra BioMed announced the publication of clinical data in JACC: Clinical Electrophysiology, demonstrating the positive effects of AVIM therapy on blood pressure and cardiac function in patients with uncontrolled hypertension. The study showed significant reductions in systolic blood pressure and improvements in left ventricular volumes. This data supports the ongoing BACKBEAT pivotal study aimed at regulatory approval for AVIM therapy.
Read more →OBIOOrchestra BioMed Announces Publication of AVIM Therapy Clinical Data in JACC: Advances Demonstrating Potential to Improve Cardiac Function in Patients with Hypertension and Diastolic Dysfunction
Orchestra BioMed announced the publication of clinical data in JACC: Advances, demonstrating that AVIM therapy significantly improves cardiac function in patients with hypertension and diastolic dysfunction. The findings indicate that AVIM therapy reduces systolic blood pressure and enhances echocardiographic markers of diastolic dysfunction. This therapy aims to address unmet medical needs in managing hypertensive heart disease.
Read more →OBIO▲ +7.9%on this newsshared move
Orchestra BioMed Reports Second Quarter 2025 Financial Results and Highlights Recent Business Updates
Orchestra BioMed reported its financial results for Q2 2025, highlighting over $111 million in proceeds from strategic transactions and equity offerings. The company achieved significant FDA regulatory milestones, including Breakthrough Device Designation for its AVIM therapy and IDE approval for the Virtue SAB trial. Despite these successes, the company reported a net loss of $19.4 million, which is an increase from the previous year, largely due to rising research and development costs. The firm also expanded its collaboration with Medtronic to enhance future development pathways.
Read more →OBIOOrchestra BioMed Announces Rollout of FDA-Approved BACKBEAT Global Pivotal Study Protocol Update Significantly Expanding Patient Eligibility
Orchestra BioMed has announced an FDA-approved protocol update for the BACKBEAT global pivotal study, greatly expanding patient eligibility criteria. This update allows for a 24-fold increase in eligible participants, including hypertensive patients who have or will receive Medtronic pacemakers. The changes aim to align the study's patient demographics with those identified for the FDA Breakthrough Device Designation for AVIM therapy. This protocol not only broadens access to participation for patients but also optimizes the study's relevance and potential impact in treating uncontrolled hypertension.
Read more →OBIOOrchestra BioMed Secures Over $111 Million in Proceeds and Committed Capital Following Completion of Strategic Transactions and Concurrent Public and Private Equity Offerings
Orchestra BioMed announced the successful completion of strategic transactions totaling approximately $111.2 million in gross proceeds from public and private equity offerings. With funding from major partners Medtronic and Ligand, the company aims to enhance its late-stage AVIM therapy and Virtue SAB clinical programs. The capital raised is expected to support critical clinical trials and extend the company’s cash runway into the second half of 2027, highlighting the confidence of its partners in the potential of these therapies.
Read more →OBIO▼ -20.3%on this newsshared move
Orchestra BioMed Announces Pricing of $40 Million Public Offering
Orchestra BioMed Holdings, Inc. announced a $40 million public offering of 9,413,637 shares of common stock priced at $2.75 each. Additionally, pre-funded warrants for 5,136,363 shares were offered at a slightly lower price. The funds raised will primarily be used to advance their atrioventricular interval modulation (AVIM) therapy program and Virtue Sirolimus AngioInfusion Balloon (SAB) program. The offering is expected to close on August 4, 2025, subject to customary conditions. Proceeds will also support general corporate needs and further the development of other product candidates.
Read more →OBIOOrchestra BioMed Announces Proposed Public Offering
Orchestra BioMed Holdings, Inc. has announced a proposed underwritten public offering of its common stock and pre-funded warrants. The company intends to utilize the net proceeds from this offering to fund its atrioventricular interval modulation therapy program, the BACKBEAT study, and the development of its Virtue Sirolimus AngioInfusion Balloon program. Additionally, the offering is subject to market conditions, and there is no guarantee regarding its completion or terms.
Read more →OBIOLigand and Medtronic Commit $70 Million in Strategic Capital to Orchestra BioMed Ligand to invest $35 million in exchange for a tiered royalty on future sales of Orchestra's AVIM therapy and Virtue SAB and an additional
Orchestra BioMed has secured a total of $70 million in strategic investments from Ligand Pharmaceuticals and Medtronic. The funding includes both equity placements and royalties from future sales of Orchestra’s AVIM therapy and Virtue SAB. This partnership aims to enhance the development of AVIM therapy-enabled leadless pacemakers, which provide a less invasive treatment option for patients with uncontrolled hypertension. Both companies expressed confidence in the potential of these innovative therapies to address significant global health challenges.
Read more →OBIO▼ -11%on this news
Orchestra BioMed Showcases AVIM Therapy as Purpose-Built Solution for Hypertensive Heart Disease at CSI Frankfurt 2025
Orchestra BioMed presented pivotal insights on its AVIM therapy for hypertensive heart disease at the CSI Frankfurt 2025 meeting. The therapy, which has received the FDA Breakthrough Device Designation, aims to address the needs of high-risk senior patients with uncontrolled hypertension and heart dysfunction. Clinical data suggests AVIM therapy can significantly lower blood pressure and improve cardiac function, offering a new treatment option in a space lacking effective therapies. The upcoming BACKBEAT global pivotal study will evaluate its efficacy in patients indicated for dual-chamber pacemakers.
Read more →OBIOOrchestra BioMed Reports First Quarter 2025 Financial Results and Highlights Recent Regulatory and Clinical Milestones
Orchestra BioMed Holdings, Inc. announced its first quarter 2025 financial results, highlighting key regulatory and clinical milestones including FDA Breakthrough Device Designation for its AVIM therapy targeting uncontrolled hypertension. The company has also secured IDE approval for the U.S. pivotal trial of its Virtue SAB device, set to compare it against the AGENT DCB. With a focus on execution, Orchestra BioMed is committed to advancing its clinical programs and generating value for stakeholders. However, the company reported an increased net loss for the quarter, raising potential financial sustainability concerns.
Read more →OBIOOrchestra BioMed’s AVIM Therapy Global Intellectual Property Estate Reaches 137 Issued Patents for the Treatment of Hypertension and Heart Failure
Orchestra BioMed announced an expansion of its global intellectual property estate for its AVIM therapy, securing a total of 137 issued patents for treating hypertension and heart failure. Over the past 12 months, ten new patents were added, particularly boosting the hypertension-focused patents to 120. The FDA's Breakthrough Device Designation for AVIM therapy highlights its potential impact on patients with uncontrolled hypertension at increased cardiovascular risk. The therapy is part of the ongoing research within the BACKBEAT global pivotal study in collaboration with Medtronic.
Read more →OBIOOrchestra BioMed Receives FDA Approval of IDE to Initiate U.S. Coronary Pivotal Trial Randomizing First-in-Class Sirolimus-AngioInfusion Balloon, Virtue SAB, Head-to-Head with Paclitaxel-Coated Balloon
Orchestra BioMed has received FDA approval for its investigational device exemption to initiate the Virtue Trial, evaluating its Sirolimus-AngioInfusion Balloon against the paclitaxel-coated AGENT balloon for treating coronary in-stent restenosis. This pivotal trial aims to assess non-inferiority, showcasing the potential clinical benefits of the Virtue SAB. The trial is set to enroll 740 patients across 75 U.S. centers, with an initiation planned for the latter half of 2025. Virtue SAB is designed to deliver extended-release sirolimus, addressing limitations of traditional drug-coated balloons.
Read more →OBIOOrchestra BioMed Announces AVIM Therapy-Focused Satellite Symposium at HRS 2025 Annual Meeting
Orchestra BioMed has announced hosting a satellite symposium at the HRS 2025 Annual Meeting to discuss advancements in its AVIM therapy for uncontrolled hypertension. The symposium, led by experts in electrophysiology and hypertension management, aims to highlight the novel therapy's clinical evidence supporting its efficacy in lowering blood pressure. The FDA has granted Breakthrough Device Designation for AVIM therapy, indicating its significance in treating patients at cardiovascular risk. Additionally, the ongoing BACKBEAT pivotal study in collaboration with Medtronic underscores the therapeutic advancements associated with this investigational device.
Read more →OBIOOrchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy Breakthrough Device Designation ("BDD") applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension a
Orchestra BioMed has received FDA Breakthrough Device Designation for its AVIM therapy, an implantable system aimed at treating uncontrolled hypertension in patients at high cardiovascular risk. This designation is expected to expedite the device's development and review processes, facilitating access to a large patient population. The therapy is currently under investigation in the BACKBEAT pivotal study, in collaboration with Medtronic. The potential benefits of AVIM could significantly impact the management options for those with hypertension who have not responded to traditional treatments.
Read more →OBIOOrchestra BioMed Reports Full Year 2024 Financial Results and Provides a Fourth Quarter Business Update
Orchestra BioMed has reported its full year 2024 financial results, showcasing both progress and challenges. The company is focused on developing AVIM therapy for hypertension and enhancing its coronary in-stent restenosis (ISR) program. Despite ongoing advancements, the financial overview highlights a net loss of $61 million and a drop in revenue from $2.6 million, attributed largely to changing partnership dynamics. The firm is also navigating a mediation process with partner Terumo to resolve strategic negotiations.
Read more →OBIO▼ -12.6%on this news
K D W Y W Y Forward - Looking Statements This presentation has been prepared for informational purposes only from information supplied by Orchestra BioMed Holdings, Inc . , referred to herein as "we," "our," "Orchestra B
Orchestra BioMed Holdings, Inc. has issued a corporate presentation detailing its growth strategies and product pipelines, particularly focusing on its Atrioventricular Interval Modulation (AVIM) therapy. The company received conditional IDE approval for a pivotal study, bolstered by promising data on safety and efficacy from prior trials. Despite substantial market potential estimated at $4 billion for artery disease and significant experience within its leadership team, the company acknowledges various risks associated with product development and regulatory approvals. Their forward-looking statements emphasize the complexity and uncertainty inherent in the biopharma sector.
Read more →OBIO▼ -8.8%on this news· ran to -19% by day 3
Orchestra BioMed to Present at Upcoming Investor Conferences
Orchestra BioMed Holdings, Inc. has announced its participation in several upcoming investor conferences, including the TD Cowen 45th Annual Healthcare Conference and the Barclays 27th Annual Global Healthcare Conference. Company management will present and engage in one-on-one meetings with investors at these events. The involvement in these conferences suggests a strategy to enhance investor relations and showcase the company's advancements in biomedical technology.
Read more →OBIOOrchestra BioMed Appoints Vivek Reddy, M.D. as Executive Chairman of the BACKBEAT Study Steering Committee and Chairman of Bioelectronic Therapies Scientific Advisory Board
Orchestra BioMed has appointed Dr. Vivek Reddy as Executive Chairman of the BACKBEAT Study Steering Committee and Chairman of the Bioelectronic Therapies Scientific Advisory Board. His role will be crucial in leading the BACKBEAT study, which focuses on the efficacy of atrioventricular interval modulation (AVIM) therapy for controlling hypertension in patients with pacemaker indications. Dr. Reddy is a recognized expert in cardiovascular technologies and aims to drive the successful completion of the study to establish the clinical value of AVIM therapy for hypertensive patients. This appointment is seen as a significant step in advancing the company's bioelectronic therapies portfolio.
Read more →OBIOOrchestra BioMed Announces Data Demonstrating Favorable Impact of AVIM Therapy on Diastolic Dysfunction, a Key Driver of Heart Failure Progression, will be Presented as Late-Breaking Science at the THT 2025 Conference
Orchestra BioMed has announced promising results from the MODERATO II study regarding its atrioventricular interval modulation (AVIM) therapy, which shows significant improvement in diastolic dysfunction in hypertensive patients. Presented as late-breaking science at the THT 2025 Conference, the data reveals that AVIM not only reduces systolic blood pressure but also positively affects diastolic filling and myocardial relaxation. These findings may provide new avenues for preventing heart failure among patients with uncontrolled hypertension, highlighting the treatment’s potential in high-risk populations. Further studies, including the ongoing BACKBEAT trial, aim to assess AVIM therapy's broader cardiovascular effects.
Read more →OBIOOrchestra BioMed Announces Appointment of Former Medtronic SVP of Corporate Development Christopher Cleary to Board of Directors Medical device industry veteran brings over three decades of expertise in M&A, as well as s
Orchestra BioMed has appointed Christopher Cleary, former SVP of Corporate Development at Medtronic, to its Board of Directors. Cleary brings extensive experience in mergers, acquisitions, and strategic R&D collaborations, which aligns with Orchestra BioMed's partnership-enabled business model. Eric A. Rose, M.D. will transition to Board Member Emeritus, continuing to provide strategic advice. Cleary's expertise is expected to help advance Orchestra BioMed's goals in medical device innovation, particularly in cardiovascular health.
Read more →OBIO▲ +9.5%on this news
Orchestra BioMed Announces AVIM Therapy Program Presentations at ICI Meeting
Orchestra BioMed has announced two significant presentations at the 2024 Innovation in Cardiology Intervention meeting in Tel Aviv, Israel. These presentations will provide insights on the BACKBEAT global pivotal study and detail the AVIM therapy, which aims to address uncontrolled hypertension in patients needing dual-chamber pacemakers. Dr. Avi Fischer will discuss the unmet medical needs of this patient population, while Dr. Andrea Russo will outline the therapy's mechanism and supporting clinical evidence. The presentations form part of a broader focus on device-based hypertension treatment in cardiology.
Read more →OBIOOrchestra BioMed to Participate in the Piper Sandler 36th Annual Healthcare Conference
Orchestra BioMed Holdings, Inc. announced its participation in the Piper Sandler 36th Annual Healthcare Conference in New York, scheduled for December 3-5, 2024. The company management will deliver a presentation format described as a fireside chat and is open to one-on-one meetings. A webcast of the presentation will be available for 90 days post-event. This participation highlights Orchestra BioMed's focus on advancing high-impact biomedical technologies.
Read more →OBIO▼ -7.7%on this news
Orchestra BioMed Reports Third Quarter 2024 Financial Results and Provides a Business Update
Orchestra BioMed reported its third quarter 2024 financial results, highlighting a strategic focus on the BACKBEAT global pivotal study in partnership with Medtronic. The company received FDA approval for an amendment to improve patient engagement in the study. Additionally, they are preparing to advance their Virtue SAB program while maintaining significant cash reserves for operational continuity. Despite a net loss of $15.4 million for the quarter, the company remains optimistic about achieving key milestones in 2025.
Read more →OBIO▼ -5.5%on this newsshared move
Orchestra BioMed to Participate in Jefferies London Healthcare Conference
Orchestra BioMed Holdings, Inc. announced its participation in the Jefferies London Healthcare Conference, scheduled for November 19-21, 2024. The event will feature a fireside chat presentation by the company's management and provide opportunities for one-on-one meetings. A webcast of the presentation will be available for 90 days post-event on the company's website. This participation emphasizes Orchestra BioMed's commitment to showcasing its technologies and engaging with the investment community.
Read more →OBIOOrchestra BioMed Reports Second Quarter 2024 Financial Results and Provides a Business Update
Orchestra BioMed Holdings, Inc. reported its second quarter 2024 financial results, highlighting the progress in its AVIM therapy for hypertension amidst a strategic collaboration with Medtronic. The company is focusing on patient enrollment for the BACKBEAT pivotal study and plans to provide updates on the Virtue SAB program in the second half of 2024. Despite a rising net loss and a slight decline in revenue, the company remains optimistic about its innovative approaches to improving patient outcomes.
Read more →OBIOOrchestra BioMed Announces Appointment of Cardiovascular Device Industry Expert John Mack to Board of Directors John Mack brings over 30 years of diverse medical device and healthcare technology experience to the Orchest
Orchestra BioMed has announced the appointment of John Mack to its Board of Directors, effective July 29, 2024. Mack brings over 30 years of experience in the medical device and healthcare technology sectors, including leadership positions at Medtronic. His addition to the board is expected to leverage his extensive industry relationships and strategic insights to drive growth and innovation at Orchestra BioMed. The company is focused on accelerating the development of high-impact medical devices, particularly in cardiovascular care.
Read more →OBIOCardiology, HTN Co-Principal Investigators Steering Committee Members JoAnn Lindenfeld Advanced Heart Failure Felix Mahfoud Interv.
The BACKBEAT study led by Orchestra BioMed focuses on the efficacy and safety of AVIM therapy in patients with uncontrolled hypertension and a dual-chamber pacemaker. Approximately 500 patients will be randomized across 80 sites in multiple countries, including the US and Europe. The primary endpoints involve evaluating changes in 24-hour ambulatory systolic blood pressure at 3 months and monitoring safety for unanticipated events. Initial results indicate favorable outcomes for patient blood pressure management with AVIM therapy, showing promising efficacy.
Read more →OBIO▲ +10.6%on this news
Orchestra BioMed Announces Further Details on In-Person R&D Day in New York Featuring Key Opinion Leaders to Discuss AVIM Therapy Program in Hypertensive Pacemaker Patients on June 11, 2024
Orchestra BioMed announced details for its upcoming in-person R&D day scheduled for June 11, 2024, at the Lotte New York Palace Hotel. The event will highlight the company's AVIM therapy, designed to treat uncontrolled hypertension in pacemaker patients, showcasing data from the MODERATO studies and introducing the BACKBEAT global pivotal study. Esteemed cardiology experts will present and discuss the therapy's mechanism and clinical evidence. A live question-and-answer session will follow the formal presentations, providing insights into AVIM therapy's potential impact.
Read more →OBIOOrchestra BioMed to Participate in Jefferies Global Healthcare Conference
Orchestra BioMed Holdings, Inc. will present at the Jefferies Global Healthcare Conference from June 4-6, 2024, in New York. Company management will host a fireside chat on June 5 at 4:00 PM ET. Attendees will have the opportunity for one-on-one meetings with the management team, potentially opening avenues for collaboration. A webcast of the presentation will be made available following the event.
Read more →OBIOOrchestra BioMed Reports First Quarter 2024 Financial Results and Provides a Business Update
Orchestra BioMed has released its financial results for the first quarter of 2024, reporting a net loss of $13.5 million. The company has successfully commenced patient enrollment for its BACKBEAT pivotal study in collaboration with Medtronic, focusing on the efficacy of AVIM therapy in hypertensive patients with pacemakers. Positive clinical results indicate significant blood pressure reductions achieved with AVIM therapy over nearly four years. However, revenue has declined significantly compared to the previous year, impacting overall financial performance.
Read more →OBIOOrchestra BioMed to Host In-Person R&D Day in New York on AVIM Therapy Program in Hypertensive Pacemaker Patients on June 11, 2024
Orchestra BioMed Holdings, Inc. will host an R&D day on June 11, 2024, in New York to discuss its lead program, AVIM therapy, for hypertensive pacemaker patients. Experts will present findings from previous studies and provide insights into the therapy's mechanism and clinical data. The event aims to address unmet medical needs in a significant population suffering from uncontrolled hypertension, particularly those with cardiac pacemakers. A live Q&A session will follow the formal presentations.
Read more →OBIOOrchestra BioMed Announces AVIM Therapy Global Intellectual Property Estate Reaches 110 Issued Patents
Orchestra BioMed Holdings, Inc. has announced that its AVIM therapy's global intellectual property estate has grown to 110 patents. This includes 37 issued U.S. patents and 73 patents issued outside the U.S., collectively covering over 1,800 claims related to hypertension treatment. The company is currently conducting a pivotal study, BACKBEAT, in partnership with Medtronic, further exploring the therapy's efficacy. Additionally, the company plans to provide an in-depth overview of AVIM therapy and the BACKBEAT study during an upcoming R&D event on June 11, 2024.
Read more →OBIOOrchestra BioMed Reports Full Year 2023 Financial Results and Provides Fourth Quarter Business Update
Orchestra BioMed Holdings, Inc. reported its financial results for 2023, highlighting a year of significant progress, including the initiation of the BACKBEAT global pivotal study for AVIM therapy aimed at hypertensive pacemaker patients. The company expects its financial position to sustain operations into the second half of 2026, despite a net loss of $49.1 million for the year. Revenue decreased due to reduced partnership earnings, while their collaboration with Medtronic and Terumo illustrates a strong strategic direction for their cardiovascular therapies.
Read more →OBIO▲ +5.2%on this newsshared move
Orchestra BioMed Announces Appointment of Medical Device Industry Expert David Pacitti to Board of Directors
Orchestra BioMed has appointed David Pacitti to its Board of Directors, effective March 26, 2024. Pacitti, currently the President of Siemens Medical Solutions USA, brings nearly 30 years of experience in the cardiovascular device and imaging sectors. His prior role as a strategic advisor to Orchestra BioMed positions him to enhance the company's strategic partnerships and opportunities in medical device innovation. The leadership at Orchestra BioMed anticipates leveraging Pacitti's expertise to drive better healthcare outcomes and improve the company's pipeline.
Read more →OBIOOrchestra BioMed Demonstrates Strength of Cardiovascular Pipeline with Virtue SAB and AVIM Therapy Presentations at CRT 2024 Annual Meeting
Orchestra BioMed announced promising presentations at the CRT 2024 Meeting regarding its cardiovascular pipeline, specifically the Virtue® Sirolimus AngioInfusion Balloon (SAB) and AVIM therapy. New pharmacokinetic data for Virtue SAB demonstrated effective sirolimus release with no polymer degradation, while AVIM therapy showed favorable hemodynamic results and long-term blood pressure reductions in hypertensive patients. The company is actively enrolling participants in the BACKBEAT pivotal study to evaluate AVIM therapy. These advancements suggest strong potential for improved treatments in cardiovascular health.
Read more →OBIO▼ -6.6%on this news· ran to -22% by day 3
Orchestra BioMed to Participate in Upcoming Investor Conferences
Orchestra BioMed Holdings, Inc. has announced its participation in several investor conferences in March 2024. The company will present at the Oppenheimer Annual Healthcare MedTech and Services Conference on March 12 and engage in a fireside chat at the Barclays Global Healthcare Conference on March 14. These events are part of Orchestra BioMed's strategy to enhance investor relations and share updates on their high-impact biomedical technologies.
Read more →OBIO▼ -6.6%on this news· ran to -22% by day 3
Orchestra BioMed Corporate Presentation Q1 2024 | Corporate Presentation Q1 2024 2 This presentation has been prepared for informational purposes only from information supplied by Orchestra BioMed Holdings, Inc . , refer
Orchestra BioMed's Q1 2024 presentation outlines the company's strategic vision and highlights the progress of its pipeline programs. The company is advancing its BackBeat CNT (AVIM therapy) aimed at managing hypertension, a critical unmet need for patients with pacemakers. A global pivotal study was initiated in December 2023, supported by positive pilot study data. Orchestra BioMed has received Breakthrough Device Designation for various indications, enhancing its position in the competitive landscape.
Read more →OBIOOrchestra BioMed Announces Presentation of Results from Clinical Study Demonstrating Favorable Hemodynamic Effects of AVIM Therapy In Hypertensive Pacemaker Patients
Orchestra BioMed has announced positive results from a clinical study evaluating its AVIM therapy for hypertensive pacemaker patients. In a trial involving 16 patients, the therapy demonstrated significant reductions in systolic blood pressure and improved hemodynamic parameters compared to standard pacing. The study's findings were presented at the THT 2024 Meeting and support the ongoing BACKBEAT pivotal study, which is actively enrolling patients to further assess the therapy's impact on hypertension management.
Read more →OBIOOrchestra BioMed Presents New Data Showing Sustained Clinically Meaningful Reduction in 24-Hour Ambulatory Systolic Blood Pressure in Hypertensive Pacemaker Patients Treated with AVIM Therapy for Over 3 Years
Orchestra BioMed announced promising results demonstrating that their AVIM therapy achieves a sustained reduction in 24-hour ambulatory systolic blood pressure by 8.9 mmHg over an average of 3.6 years in hypertensive pacemaker patients. These results stem from a follow-up study of patients from the MODERATO II trial. The company is currently enrolling participants for the BACKBEAT pivotal study to further evaluate the efficacy and safety of AVIM therapy. This innovative approach aims to improve management of hypertension in patients who face difficulties despite traditional treatments.
Read more →OBIO▲ +9.4%on this news
Orchestra BioMed Announces Initiation of BACKBEAT Pivotal Study of AVIM Therapy in Hypertensive Pacemaker Patients
Orchestra BioMed announced the initiation of the BACKBEAT pivotal study, evaluating AVIM therapy for pacemaker patients with uncontrolled hypertension. The study aims to assess the safety and efficacy of this investigational therapy, which is designed to reduce blood pressure using standard pacemakers. In collaboration with Medtronic, this pivotal clinical trial will involve approximately 500 patients across the U.S. and Europe, targeting a crucial gap in treatment for hypertensive patients in need of pacemaker interventions. Initial pilot study results suggest promising outcomes, paving the way for further investigation.
Read more →OBIO▲ +13.1%on this news
Orchestra BioMed Corporate Presentation Q4 2023 | Corporate Presentation Q4 2023 2 This presentation has been prepared for informational purposes only from information supplied by Orchestra BioMed Holdings, Inc . , refer
Orchestra BioMed Holdings, Inc. has presented a corporate overview for Q4 2023, emphasizing its strategic plans and potential for significant market opportunities in hypertension and coronary artery conditions. The company highlighted its expected cash runway extending into the second half of 2026 and the commencement of a global pivotal study. Additionally, Orchestra BioMed announced its collaboration with Medtronic, enhancing the prospects for its AVIM therapy and corresponding product candidates, which have received Breakthrough Device Designation from the FDA. The emphasis was placed on the positive outcomes from prior pilot study trials and the potential for leveraging existing reimbursement structures.
Read more →OBIO▲ +14.6%on this news· ran to +32% by day 3shared move
Orchestra BioMed Reports Third Quarter 2023 Financial Results and Provides Business Update
Orchestra BioMed has announced third quarter 2023 financial results and significant regulatory advancements. The U.S. FDA granted Investigational Device Exemption approvals for pivotal studies of its BackBeat CNT therapy and Virtue SAB. The BACKBEAT study is expected to commence enrollment soon, with a potential completion date targeted for mid-2025. Financially, the company reported a net loss of $13.3 million for the quarter, an increase from the previous year, while its operating cash runway extends into the second half of 2026.
Read more →OBIOOrchestra BioMed Corporate Presentation Q4 2023 | Corporate Presentation Q4 2023 2 Forward - Looking Statements This presentation has been prepared for informational purposes only from information supplied by Orchestra B
Orchestra BioMed has released its Q4 2023 corporate presentation indicating a strong balance sheet and ongoing clinical programs. The company plans to initiate pivotal trials in 2024, backed by promising preliminary data from multi-center studies. It has received Breakthrough Device Designation for its Virtue Sirolimus AngioInfusion Balloon, aiming to target significant market opportunities in artery disease. However, the presentation also highlights reliance on forward-looking statements and the inherent risks associated with regulatory approvals and market conditions.
Read more →OBIO▲ +27.6%on this news
Orchestra BioMed Granted FDA Approval of IDE to Initiate BACKBEAT Pivotal Study of BackBeat CNT for the Treatment of Hypertension in Pacemaker Patients Hypertension is the most common comorbidity in the pacemaker populat
Orchestra BioMed has received FDA approval for an investigational device exemption to initiate the BACKBEAT pivotal study, aimed at evaluating the efficacy and safety of AVIM therapy for treating hypertension in pacemaker patients. This global study will involve approximately 500 participants who have uncontrolled hypertension despite current medical therapies. The company, in collaboration with Medtronic, aims to advance this innovative treatment, leveraging promising results from earlier trials. The study is set to begin enrollment by the end of 2023, paving the way for potential regulatory approvals.
Read more →OBIO▲ +7.1%on this news
Orchestra BioMed Reports Second Quarter 2023 Financial Results and Provides Business Update
Orchestra BioMed announced its second quarter financial results, highlighting key business updates. The FDA has granted conditional IDE approval for the pivotal study of its Virtue SAB product, expected to start by year-end. The company is set to initiate a global pivotal study of BackBeat CNT for hypertension, also in the second half of 2023. While financial results showed a higher net loss and increased expenses, Orchestra BioMed maintains a strong cash position to support its growth strategy into 2026.
Read more →OBIOOrchestra BioMed™ Granted FDA Approval of IDE for U.S. Pivotal Study of Virtue Sirolimus AngioInfusion Balloon™ in Patients with Coronary In-Stent Restenosis
Orchestra BioMed has received FDA approval for an Investigational Device Exemption (IDE) to initiate the Virtue ISR-US pivotal study assessing the Virtue Sirolimus AngioInfusion Balloon (SAB) in patients with coronary in-stent restenosis (ISR). The study, which aims to evaluate the efficacy and safety of Virtue SAB compared to traditional balloon angioplasty, is expected to commence before the end of 2023. This approval is backed by promising results from an earlier pilot study highlighting Virtue SAB's potential to address a significant clinical need in coronary artery treatment.
Read more →OBIO▼ -5.1%on this news
Orchestra BioMed Corporate Presentation Q3 2023 2 | Corporate Presentation Q2 2023 Forward-Looking Statements This presentation has been prepared for informational purposes only from information supplied by Orchestra Bio
Orchestra BioMed's recent presentation highlighted key updates on their cardiovascular programs, including the CNT-HF and SirolimusEFR projects. The company showcases a robust pipeline entering pivotal trials backed by strong financial support and partnerships. Notable preliminary efficacy results indicate potential safety and effectiveness, particularly in coronary in-stent restenosis (ISR) treatments. The upcoming regulatory milestones position Orchestra BioMed favorably within large market segments.
Read more →OBIO▲ +9.3%on this newsshared move
Orchestra BioMed Corporate Presentation Q2 2023 | Corporate Presentation Q2 2023 2 Forward - Looking Statements This presentation has been prepared for informational purposes only from information supplied by Orchestra B
Orchestra BioMed presented its corporate update for Q2 2023, highlighting its strategic collaborations and a strong financial position. The company plans to initiate pivotal trials in the second half of 2023 and has reported promising preliminary trial data. However, the outlook is tempered by the reliance on regulatory approvals and inherent uncertainties in clinical trial timelines. The potential for competition in the market also poses risks to the company's future success.
Read more →OBIO▼ -9.8%on this news· ran to -22% by day 1
Orchestra BioMed Set to Join Russell 3000 and other FTSE Russell Indexes
Orchestra BioMed Holdings, Inc. has announced its forthcoming inclusion in the Russell 3000 Index, Russell 2000 Index, and Russell Microcap Index, effective June 26, 2023. This decision follows a ranking of the largest U.S. stocks by market capitalization and is expected to enhance the company's visibility in the investment community. The Russell indexes are used broadly by investment managers and institutional investors, which may lead to increased investment opportunities for Orchestra BioMed.
Read more →OBIO▼ -7.5%on this news
Bringing medical inn vation to life Bringing medical inn vation to life Orchestra BioMed Corporate Presentation Q2 2023 Forward - Looking Statements 2 This presentation has been prepared for informational purposes only f
Orchestra BioMed has presented a corporate update for Q2 2023, highlighting its strategic collaborations and robust financial health. The company aims to initiate pivotal trials in the second half of 2023, showcasing promising preliminary trial efficacy data for its product candidates. However, the document emphasizes the inherent risks associated with forward-looking statements, particularly regarding regulatory approvals and changing market conditions. The firm continues to navigate a competitive landscape while fostering partnerships to drive growth and innovation.
Read more →OBIO▼ -6.4%on this newsshared move
Orchestra BioMed Appoints Bill Little as Executive Vice President of Corporate Development and Strategy and Andrew Taylor as Chief Financial Officer
Orchestra BioMed has appointed Bill Little as Executive Vice President of Corporate Development and Strategy, and Andrew Taylor as Chief Financial Officer. Little brings extensive experience from his previous role at Neovasc, while Taylor has over 20 years of financial leadership in the medical device sector. This newly structured executive team aims to enhance the company's strategy for partnerships and innovation in biomedical technologies. The appointments are expected to support Orchestra BioMed's goals of expanding its product pipeline and driving successful global commercialization.
Read more →OBIO▲ +8.9%on this news
Orchestra BioMed to Present at the Jefferies Global Healthcare Conference
Orchestra BioMed Holdings, Inc. will present at the Jefferies Global Healthcare Conference on June 8, 2023, in New York. Company management will be available for one-on-one meetings during the event. The company's forward-looking statements indicate potential growth and opportunities, although they acknowledge inherent uncertainties in their forecasts. A replay of the presentation will be accessible for 90 days following the event, providing further engagement for interested stakeholders.
Read more →OBIOOrchestra BioMed Reports First Quarter 2023 Financial Results and Provides Business Update
Orchestra BioMed has reported its financial results for Q1 2023, highlighted by a successful business combination that raised approximately $70 million. The company plans to initiate pivotal studies for its BackBeat CNT and Virtue SAB products in collaboration with Medtronic and Terumo, respectively, in the latter half of 2023. Despite the positive cash position and strategic collaborations, the company reported a net loss of $10.9 million, indicating financial challenges in the short term. Continued investments in research and development reflect the company’s focus on bringing innovative therapies to market.
Read more →OBIOIndex to Consolidated Financial Statements Financial Statements for Orchestra Biomed, Inc. (accounting predecessor to Orchestra Biomed Holdings, Inc): Years Ended
Orchestra Biomed, Inc. has released its consolidated financial statements for the years ending December 31, 2021, and 2022. The independent audit found that the financial statements present a fair view of the company's financial position. Despite an increase in total assets, the company experienced significant net losses, escalating from $23,014 in 2021 to $33,608 in 2022, alongside a growing accumulated deficit. The financial health of the company appears to be deteriorating based on these results.
Read more →OBIO▲ +13.9%on this news
Bringing medical inn vation to life Orchestra BioMed Corporate Presentation Q1 2023 Forward - Looking Statements 2 This presentation has been prepared for informational purposes only from information supplied by Orchestr
Orchestra BioMed provided a corporate presentation outlining their strategic initiatives and innovations in medical technology for Q1 2023. The presentation highlighted forward-looking statements regarding financial performance, product efficacy, and trial timelines. Key highlights included the development of a partnership-enabled business model aimed at product innovation and substantial upcoming pivotal trials for their product candidates. Despite these developments, the company acknowledges inherent risks and uncertainties associated with their forward-looking statements and business operations.
Read more →OBIOOrchestra BioMed Announces Upcoming Presentations on BackBeat CNT™ and Virtue SAB at CRT 2023
Orchestra BioMed Holdings, Inc. announced that data from its BackBeat Cardiac Neuromodulation Therapy and Virtue Sirolimus AngioInfusion Balloon programs will be presented at the Cardiovascular Research Technologies 2023 Meeting. Scheduled oral presentations include research on reducing hypertension through BackBeat CNT and an overview of Virtue SAB's applications for artery diseases. The collaborations with prominent companies like Medtronic and Terumo enhance Orchestra BioMed's potential for advancing these technologies and reaching global commercialization.
Read more →OBIOOrchestra BioMed Strengthens Senior Leadership Team
Orchestra BioMed Holdings, Inc. has announced significant changes in its senior leadership team by appointing Avi Fischer, M.D. as Senior Vice President of Medical Affairs and Innovation, and J.C. Simeon as Senior Vice President of Quality. Additionally, George Papandreou, Ph.D. has been promoted to General Manager and SVP of Focal Therapies, while Kunal Faldu has been elevated to Vice President of Pharmaceutical Development. The new leadership members bring extensive experience in their respective fields, which aims to enhance the development of the company’s innovative medical technologies.
Read more →OBIOOrchestra BioMed Debuts as Nasdaq-Traded Company with Lead Programs Targeting Hypertension and Artery Disease and Novel Partnership-Enabled Business Model Business combination with Health Sciences Acquisitions Corporatio
Orchestra BioMed has successfully completed its business combination with Health Sciences Acquisitions Corporation 2, debuting on Nasdaq under the ticker "OBIO." The merger brings approximately $180 million in gross proceeds, which will fund pivotal studies for its lead products targeting hypertension and artery disease. The company aims to leverage its innovative partnership-enabled business model, collaborating with major medtech players like Medtronic and Terumo. This financial backing positions Orchestra BioMed well for future growth and development in the biomedical sector.
Read more →OBIOOrchestra BioMed™ Announces Presentation of Positive Long-Term Clinical Results from MODERATO II Control Patients Crossover Extension Study of BackBeat CNT™ at TCT 2022
NEW HOPE, Pa., Sept. 20, 2022 (GLOBE NEWSWIRE) -- Orchestra BioMed™, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies, toda
Read more →OBIOOrchestra BioMed™ Announces Strategic Collaboration, Closing of $110 Million Private Equity Financing and Plans to List on Nasdaq Through Merger with Health Sciences Acquisitions Corporation 2
Strategic collaboration with Medtronic to develop BackBeat Cardiac Neuromodulation Therapy™ as potential integrated hypertension treatment for cardiac pacemaker patients Investors in $110 million Series D financing include Medtronic and Terumo as well as lead investor RTW Invest
Read more →OBIOBringing medical inn vation to life Orchestra BioMed Corporate Presentation July 2022 Important Notice and Disclaimer This investor presentation (this "Presentation") is for informational purposes only to assist interest
Bringing medical inn vation to life Orchestra BioMed Corporate Presentation July 2022 Important Notice and Disclaimer This investor presentation (this "Presentation") is for informational purposes only to assist interested parties in making their own evaluation with respect to
Read more →OBIOHEALTH SCIENCES ACQUISITIONS CORPORATION 2 Report of Independent Registered Public Accounting Firm F-2 Balance Sheet as of
SCIENCES ACQUISITIONS CORPORATION 2 Report of Independent Registered Public Accounting Firm F-2 Balance Sheet as of August 6, 2020 F-3 Notes to Balance Sheet F-4 Report of Independent Registered Public Accounting Firm To the Shareholders and the Board of Directors Health Scie
Read more →OBIOOrchestra BioMed™ Appoints Drug-Device Combination Expert Jagdish Parasrampuria as Vice President of Pharmaceutical Development
NEW HOPE, Pa., July 13, 2020 (GLOBE NEWSWIRE) -- Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company focused on developing transformative therapeutic products for large unmet needs in procedure-based medicine, today announced the appointm
Read more →OBIOOrchestra BioMed™ Enhances Management Team with Appointment of Regulatory Affairs and Combination Product Expert Bob Laughner as Vice President, Regulatory Affairs
NEW HOPE, Pa., April 28, 2020 (GLOBE NEWSWIRE) -- Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing transformative therapeutic products for large unmet needs in procedure-based medicine, today announced the appointment of Bob
Read more →OBIOOrchestra BioMed™ Strengthens Management Team with Appointments of Expert Product Development Leaders Juan A. Lorenzo and Paul V. Goode, Ph.D.
NEW HOPE, Pa., Oct. 16, 2019 (GLOBE NEWSWIRE) -- Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, today announced senior-level appointments to its produ
Read more →OBIOOrchestra BioMed™ Appoints Dennis Donohoe, M.D., Leading Clinical Development Expert, as Chief Medical Officer
NEW HOPE, Pa., Aug. 27, 2019 (GLOBE NEWSWIRE) -- Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, today announced the appointment of Dennis Donohoe, M.D
Read more →OBIOOrchestra BioMed™ Appoints C. Evan Ballantyne as Chief Financial Officer
- Industry veteran brings over 25 years of financial and operational management experience with a proven track record of developing and implementing successful strategies to drive growth and build shareholder value - NEW HOPE, Pa., Dec. 04, 2018 (GLOBE NEWSWIRE) -- Orchestra Bio
Read more →OBIOOrchestra BioMed™ Announces Completion of $41 Million Financing
Capital proceeds to support late-stage clinical development of lead cardiovascular product candidates for artery disease and hypertension Financing structure provides for up to an additional $23 million in follow-on financing from existing investors NEW HOPE, Pa., Nov. 15, 2018
Read more →OBIOOrchestra BioMed™ Strengthens Operations, R&D and Pharmaceutical Development Expertise with Key Leadership Team Additions
– Ron Dadino appointed Vice President, Pharmaceutical Development & Operations, Cardiovascular Interventions – – Greg Kopia, Ph.D., CMPP appointed Director, Pre-Clinical Development, Cardiovascular Interventions – – Ziv Belsky appointed Vice President, Research & Development, C
Read more →OBIOOrchestra BioMed™ Adds Three Industry Leaders to Strategic Advisory Board
Eric A. Rose, M.D., biotech and medical device business leader as well as world-renowned cardiac surgeon and scientist who performed the landmark achievement of the first successful pediatric heart transplant Jason Aryeh, life sciences industry expert, investment fund manager an
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