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Envoy Medical Reports Third Quarter 2024 Results and Other Exciting Events FDA approval to begin pivotal trial of fully implanted cochlear implant and AMA approval of CPT codes for the Company's already FDA-approved full

Key Takeaway: Envoy Medical announced its financial results for the third quarter of 2024 along with significant milestones for its products. The company received FDA approval to initiate a pivotal trial for its Acclaim fully implanted cochlear implant and obtained AMA approval for new CPT codes related to middle ear implants. Despite these positive developments, Envoy reported a decrease in net revenues primarily due to fewer battery replacement requests and ongoing supply chain challenges. The company emphasized its commitment to advancing reimbursement strategies for its innovative hearing devices.

Market Sentiment Analysis

POSITIVE FACTORS

  • FDA approval to begin pivotal trial of the Acclaim cochlear implant.
  • AMA approved Category III CPT codes for implantable middle ear devices.
  • Continued progress on reimbursement strategies for the Esteem device.

CONCERNS & RISKS

  • Net revenues decreased from $80K to $56K compared to Q3 2023.
  • Decreased number of battery replacement requests impacted revenue.
  • Supply chain issues contributed to revenue declines.

Full Press Release Details

Medical Reports Third Quarter 2024 Results and Other Exciting Events
FDA approval to begin pivotal trial of
fully implanted cochlear implant and AMA approval of CPT codes for the Company's already FDA-approved fully implanted middle ear
implant are two of the exciting developments for the growing company
WHITE BEAR LAKE, Minn., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Envoy
Medical , Inc. ("Envoy Medical") (Nasdaq: COCH), a revolutionary hearing health company focused on fully implanted hearing
devices, today announces its corporate and financial results for the third quarter ended September 30, 2024, as well as other subsequent events.
"The progress and accomplishments of
late have been extremely important to Envoy Medical as they have set the stage for us to demonstrate the value of fully implanted hearing
devices. First, we have received FDA's approval to start our pivotal trial of the Acclaim fully implanted cochlear implant
("Acclaim CI"). Second, we continue to make tremendous progress on obtaining meaningful reimbursement for our already FDA-approved
Esteem FI-AMEI. We continue to receive considerable support for the bipartisan bills that were introduced in both the House and the
Senate this year to change the way fully implanted active middle ear hearing devices classified by CMS. In addition, the American Medical
Association's CPT Editorial Panel has approved Category III CPT codes for totally implantable active middle ear hearing devices
for the first time. A significant step forward for our Esteem device. Ultimately, we continue to believe that our products are important
innovations for patients suffering from hearing loss and foresee a bright future for Envoy Medical," commented Brent Lucas, Envoy
Medical's Chief Executive Officer. "We look forward to updating shareholders on our progress as we initiate the trial for
the Acclaim device and as we progress with our reimbursement strategy for the Esteem device."."
Corporate Highlights from Q3 2024 and To Date
Financial Results for the Quarter Ended September 30, 2024
Net revenues were $56 thousand for the quarter ended September 30,
2024, a decrease of $24 thousand from $80 thousand for the same period in 2023. Net revenues were $183 thousand for the nine months ended
September 30, 2024, a decrease of $38 thousand compared to the previous period. Both decreases were due mainly to a reduction in the number
of battery replacement requests for Esteem implants received during the noted periods, and also as a result of supply chain issues.
R&D expenses increased $907 thousand from $1.9 million to $2.8
million for the three months ended September 30, 2024, and the nine-month results showed an increase of $1.8 million from $5.9 million
to $7.7 million for September 30, 2024. Both increases were due to costs associated with additional headcount and contractors across our
clinical and engineering departments in preparation for the pivotal clinical study for the Acclaim CI.
Sales and marketing expenses decreased by $5 thousand for the three
months ended September 30, 2024 as compared to the same period for 2023, although for the nine months ended September 30, 2024 increased
by $63 thousand compared to the same period in 2023. For the year to date results, increases in legal and professional fees to secure
insurance reimbursement for the Esteem FI-AMEI product were offset by reductions in headcount.
General and administrative expenses increased by $665 thousand to $1.7
million for the three months ended September 30, 2024, and the year-to-date results showed a $1.2 million increase over the prior year.
The increases are due primarily to increased legal and professional fees normally associated with being a publicly traded company and
other administrative expenses.
As of September 30, 2024, cash and cash equivalents were approximately
About the Fully Implanted Acclaim
We believe the fully implanted Acclaim Cochlear
Implant ("Acclaim CI") is a first-of-its-kind hearing device. Envoy Medical's fully implanted technology includes a
sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.
The Acclaim CI is designed to address severe
to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for
adults who have been deemed adequate candidates by a qualified physician.
The Acclaim Cochlear Implant received the
Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.
CAUTION The fully implanted Acclaim Cochlear Implant is an investigational
device. Limited by Federal (or United States) law to investigational use.
About the Esteem Fully Implanted Active
Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear
implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural
hearing loss allowing for 24/7 hearing capability using the ear's natural anatomy. The Esteem FI-AMEI hearing implant is invisible
and requires no externally worn components and nothing is placed in the ear canal for it to function. Unlike hearing aids, you never put
it on or take it off. You can't lose it. You don't clean it. The Esteem FI-AMEI hearing implant offers true 24/7 hearing.
Important safety information for the Esteem
Additional Information and Where to Find
Copies of the documents filed by Envoy Medical
with the SEC may be obtained free of charge at the SEC's website at www.sec.gov.
Forward-Looking Statements
This press release includes "forward-looking
statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform
Act of 1995. Forward-Looking statements may be identified by the use of words such as "estimate," "plan," "project,"
"forecast," "intend," "will," "expect," "anticipate," "believe,"
"seek," "target" or other similar expressions that predict or indicate future events or trends or that are not
statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements
may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity,
plans and goals for future operational improvements and capital investments; the Acclaim CI being the first to market fully implanted
cochlear implant, the result of the clinical trial, the timing and results of clinical trials of the Acclaim CI, and the participation
of any institution in such trials; the safety, performance, and market acceptance of the Acclaim CI; and any information concerning possible
or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical's
current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances
that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not
guarantee that the events described will happen as described (or that they will happen at all). These forward-looking statements are subject
to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical's Class
A Common Stock; changes in or removal of Envoy Medical's shares inclusion in any index;
Envoy Medical's success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability
in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical
products; competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at
competitive prices to compete successfully against competitors; disruptions in relationships with Envoy Medical's suppliers, or
disruptions in Envoy Medical's own production capabilities for some of the key components and materials of its products; changes
in the need for capital and the availability of financing and capital to fund these needs; changes in interest rates or rates of inflation;
legal, regulatory and other proceedings could be costly and time-consuming to defend; changes in applicable laws or regulations, or the
application thereof on Envoy Medical; a loss of any of Envoy Medical's key intellectual property rights or failure to adequately
protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts;
and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward
Looking Statements" in the Annual Report on Form 10-K filed by Envoy Medical on April 1, 2024, and in other reports Envoy Medical
files, with the SEC. If any of these risks materialize or Envoy Medical's assumptions prove incorrect, actual results could differ
materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical's
good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise
any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events
or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any
forward-looking statements, which are based only on information currently available to Envoy Medical.
Chief Financial Officer
CONSOLIDATED BALANCE SHEETS
thousands, except share and per share amounts)
September 30, 2024 December 31, 2023
Assets
Current assets:
Cash $ 4,424 $ 4,218
Accounts receivable, net 197 70
Other receivable 32 176
Inventories 1,641 1,404
Prepaid expenses and other current assets 842 957
Total current assets 7,136 6,825
Property and equipment, net 1,197 351
Operating lease right-of-use asset (related party) 1,064 464
Total assets $ 9,397 $ 7,640
Liabilities and stockholders' deficit
Current liabilities:
Accounts payable $ 1,757 $ 1,554
Accrued expenses 6,854 4,613
Product warranty liability, current portion 238 311
Operating lease liability, current portion (related party) 225 158
Total current liabilities 9,074 6,636
Term loan payable and accrued interest (related party) 14,356 -
Product warranty liability, net of current portion 1,923 1,923
Operating lease liability, net of current portion (related party) 1,028 404
Publicly traded warrant liability 1,134 332
Forward purchase agreement put option liability - 103
Forward purchase agreement warrant liability 411 4
Total liabilities 27,926 9,402
Commitments and contingencies (see Note 14)
Stockholders' deficit:
Series A Preferred Stock, $0.0001 par value; 100,000,000 shares authorized and 10,000,000 shares designated as of September 30, 2024 and December 31, 2023; 4,500,000 shares issued and outstanding as of September 30, 2024 and December 31, 2023 - -
Class A Common Stock, $0.0001 par value; 400,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 19,730,982 and 19,599,982 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 2 2
Additional paid-in capital 259,119 255,596
Accumulated deficit (277,529 ) (257,242 )
Accumulated other comprehensive loss (121 ) (118 )
Total stockholders' deficit (18,529 ) (1,762 )
Total liabilities and stockholders' deficit $ 9,397 $ 7,640

Frequently Asked Questions

What trial has Envoy Medical received FDA approval for?

Envoy Medical received FDA approval to start a pivotal trial for the Acclaim CI.

How does the Esteem FI-AMEI differ from regular hearing aids?

The Esteem FI-AMEI is a fully implanted device that provides 24/7 hearing without external components.

What were Envoy Medical's Q3 2024 net revenues?

Net revenues for Q3 2024 were $56 thousand, down from $80 thousand in Q3 2023.

What is the Acclaim Cochlear Implant designed for?

The Acclaim CI aims to address severe to profound sensorineural hearing loss.

What support is Envoy Medical receiving for reimbursement?

The company is gaining support for bipartisan bills changing CMS classifications for hearing devices.

Last updated: Nov 14, 2024