Latest news with #Acclaim
Associated Press
31-03-2025
- Business
- Associated Press
Envoy Medical Reports Fourth Quarter and Full Year 2024 Financial Results
Company Provides Corporate Update that Includes Information on its Progress Enrolling Subjects in its Pivotal Clinical Study for Breakthrough Device, the Fully Implanted Acclaim® Cochlear Implant White Bear Lake, Minnesota--(Newsfile Corp. - March 31, 2025) - Envoy Medical®, Inc. (NASDAQ: COCH) ('Envoy Medical'), a revolutionary hearing health company focused on fully implanted hearing devices, today announced its corporate and financial results for the fourth quarter and full year ended December 31, 2024, as well as other subsequent events. Brent Lucas, CEO of Envoy Medical commented: 'Envoy Medical had a successful 2024 and we are off to a wonderful start in 2025. Obtaining FDA's approval to begin our pivotal clinical trial for the fully implanted Acclaim cochlear implant was a milestone many years in the making, and we are very excited to report that enrollment is going extremely well. The investigational sites are reporting a tremendous amount of patient interest in our fully implanted cochlear implant. We believe we have a special product and a great opportunity to change the hearing implant industry. We are also pleased with the progress surrounding the Hearing Device Coverage Clarification Act, which, if passed, could provide our Esteem ® implant with a pathway to Medicare coverage. In addition, the establishment of new CPT codes for fully implanted active middle ear implants, which become effective in July of this year, furthered our efforts in the quest for the Esteem implant to become a reimbursed product.' Financial and Corporate Highlights for 2024 and to date: Continued to make modifications that have shown promising reduction in previously discussed electrical system noise (i.e., not physiological or 'body noise') in initial results of the Early Feasibility Trial of the fully implanted Acclaim ® cochlear implant. Several modifications in firmware, software, programming, protocol design, and hardware incorporated into Pivotal Clinical Trial. All three previously implanted Early Feasibility Trial patients have successfully completed 24 months of follow-up. No reported Unanticipated Device Events or Serious Adverse Device Effects. Received FDA approval to initiate a staged Pivotal Clinical Trial for its fully implanted Acclaim ® cochlear implant. Selected seven top-tier cochlear implant programs as investigational sites for the Pivotal Clinical Trial. To date, six of the planned 10 participants in the Pivotal Clinical Trial's first stage have been enrolled and implanted, two of which have been activated. Continued to push for the bipartisan Hearing Device Coverage Classification Act, which seeks to clarify that Implanted Active Middle Ear Implants are prosthetics, not hearing aids, making them eligible for Medicare coverage. The respective bills were reintroduced in both the US House of Representatives and US Senate for the 119 th Congress. Reported that the American Medical Association approved groundbreaking new CPT codes for totally implantable active middle ear hearing implants opening new potential opportunities for Envoy Medical's fully implanted active middle ear implant – the Esteem ® device. Reported that it continued to increase its portfolio of patents and intellectual property. Financial Results from YE 2024 Net revenues decreased $91 thousand for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to the decrease in the number of battery replacement sales due to supply chain limitations. Cost of goods sold decreased $47 thousand for the same period and is aligned with the decrease in revenue resulting from the reduced number of Battery replacement sales. R&D expenses increased $1.2 million for the year ended December 31, 2024 compared to the year ended December 31, 2023. The increase is primarily due to an increase in headcount and contractors in our engineering and clinical departments for December 31, 2024, as we increased headcount in preparation for our pivotal clinical study for the Acclaim CI. These increases in headcount included the addition of five new engineers, a clinical research associate, and a clinical research director. Sales and marketing expenses increased $68 thousand for the year ended December 31, 2024 compared to the year ended December 31, 2023. The increase is primarily due to increased legal and professional fees to secure insurance reimbursement for the Esteem FI-AMEI product, partially offset by a reduction in headcount. General and administrative expenses decreased $438 thousand for the year ended December 31, 2024 compared to the year ended December 31, 2023. The decrease is primarily due to reduced professional service costs in 2024 compared to 2023 related to the Business Combination transaction occurring in September 2023. As of December 31, 2024 cash and cash equivalents were approximately $5.5 million. About the Fully Implanted Acclaim® Cochlear Implant 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. *Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use. Important safety information for the Esteem FI-AMEI can be found at: Additional Information and Where to Find It Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC's website at 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 timing and results of IRB approvals, site documents, logistics or activations, enrollments, and clinical trials of the Acclaim CI, and the participation or any changes in participation of any institution or healthcare professionals in such trials; the Acclaim CI being the first to market fully implanted cochlear implant; 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 March 28, 2025, 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. Investor Relations: Envoy Medical Investor Relations Media Contact: [email protected] ENVOY MEDICAL, INC. CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts) [This table cannot be displayed. Please visit the source.] ENVOY MEDICAL, INC. (In thousands, except share and per share amounts) [This table cannot be displayed. Please visit the source.] ENVOY MEDICAL, INC. (In thousands)
Yahoo
05-03-2025
- Entertainment
- Yahoo
Legendary 1990s publisher Acclaim is back from the dead, and a pro wrestler famous for clobbering people with a guitar is on its advisory board
When you buy through links on our articles, Future and its syndication partners may earn a commission. If you're a gamer of a certain age, the name Acclaim will ring some pretty loud bells. It was a big-time videogame publisher through the late 1980s and '90s, with a number of major sports and entertainment partnerships to its name. Flagging sales forced the company to declare bankruptcy in 2004 but now it's back, in name at least, and aiming to "support indie developers and reignite classic franchises." "Acclaim will provide much-needed resources such as funding, marketing and PR support, giving independent studios the opportunity to bring their creative visions to a broad audience," Acclaim said in its rejuvenation announcement. "One of the key goals for the relaunched Acclaim is to resurrect and revitalize its beloved portfolio of classic IP enjoyed for years by millions of players. To ensure this vision comes to life, Acclaim has assembled an advisory board comprised of esteemed industry leaders, including Russell Binder at Striker Entertainment, Mark Caplan at Ridge Partners, and Jeff Jarrett at Global Force Entertainment." This is the part of the otherwise entirely boilerplate announcement that caught my attention. Surely, I thought to myself, they're not talking about Double-J Jeff Jarrett, the veteran pro wrestler known for smashing guitars over the heads of pretty much anyone who catches his attention? Yup, that is exactly who they're talking about. "For more than three decades, I've had the privilege to have been a part of both the wrestling and gaming universes, and I'm thrilled to now be a partner in the revival of Acclaim, an iconic publisher known for releasing some of the most legendary games of the '80s and '90s," Jarrett said. "From my early involvement with the publisher's hit 16-bit WWF titles to my experience helping shape the TNA Wrestling series, which spawned the first video game wrestler to become a full-time roster member in the Squared Circle, I've seen firsthand the type of impact great games can have on players and fans. Resurrecting Acclaim is an opportunity to impart the same degree of passion and love to a new generation, and I'm excited to be involved." Another interesting bit of trivia: One of the financial backers of the revived Acclaim is VaynerFund partner Phil Toronto, who is not actually from Toronto. That is his real name, though. The new Acclaim will be headed up by CEO Alex Josef, who has a number of credits to his name as CEO of publisher Graffiti Games. "It's an absolute honor and pleasure to be leading the charge in bringing Acclaim back to the forefront of the games industry," Josef said. "We're fortunate that we have an extremely talented team and that we've already signed some incredible indie titles, which we'll be revealing soon." To be blunt, I'm a little doubtful about how much weight the Acclaim name carries these days. But if the resurrected company is able to follow through on its new mission statement and offer meaningful support for indie developers, then I'm all for it. Best laptop games: Low-spec lifeBest Steam Deck games: Handheld must-havesBest browser games: No install neededBest indie games: Independent excellenceBest co-op games: Better together
Yahoo
04-03-2025
- Entertainment
- Yahoo
Acclaim is back from the ashes to support indie games and revive its own classic franchises
Acclaim was one of the biggest gaming brands in the '80s and '90s, but the company ran into trouble in the the early 2000s. It filed for bankruptcy in 2004 and it was sold off in parts. Now, more than twenty years later, a group of industry veterans has revived the publisher with the aim of supporting indie developers and revitalizing its own gaming franchises. The company will help indie studios on the funding, marketing and PR fronts. That's very welcome news, especially at a time when funding is tougher to come by. Acclaim's plan to revive its own catalog of gaming IP is pretty exciting too. The company, which was founded in 1987, published the console and PC versions of the NBA Jam and Mortal Kombat series, as well as a string of licensed games, including WWF titles, The Simpsons: Bart's Nightmare, Spider-Man games, Alien 3, Terminator 2: Judgement Day, Space Jam and many more. Acclaim also published the first games in the Burnout and Turok franchises. CEO Alex Josef said in a press release that Acclaim has already signed some indie games and it plans to reveal those soon. But here's hoping the publisher gives the people what they really want: a modern take on NBA Jam.
