Elutia(ELUT)

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Elutia to Present at the Emerging Growth Conference on Thursday, July 18
GlobeNewswire News Room· 2024-07-11 20:05
SILVER SPRING, Md., July 11, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) ("Elutia"), a pioneer in drug-eluting biomatrix products, today announced that Dr. Randy Mills, President and Chief Executive Officer, will present at the Emerging Growth Conference on Thursday, July 18, 2024, at 12:35 p.m. ET (9:35 a.m. PT). About Elutia The Emerging Growth conference is an effective way for public companies to present and communicate their new products, services and other major announcements to the investment ...
Elutia Announces $13.26 Million Registered Direct Offering
GlobeNewswire News Room· 2024-06-17 12:01
SILVER SPRING, Md., June 17, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) ("Elutia" or the "Company") today announced it has entered into a definitive agreement with investors for the purchase and sale of 3,175,000 shares of the Company's Class A common stock at a purchase price of $3.40 per share and 725,000 prefunded warrants to purchase up to 725,000 shares of the Company's Class A common stock at a purchase price of $3.399 per prefunded warrant in a registered direct offering. The prefunded warra ...
Elutia Announces $13.26 Million Registered Direct Offering
Newsfilter· 2024-06-17 12:01
SILVER SPRING, Md., June 17, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) ("Elutia" or the "Company") today announced it has entered into a definitive agreement with investors for the purchase and sale of 3,175,000 shares of the Company's Class A common stock at a purchase price of $3.40 per share and 725,000 prefunded warrants to purchase up to 725,000 shares of the Company's Class A common stock at a purchase price of $3.399 per prefunded warrant in a registered direct offering. The prefunded warra ...
Elutia Announces FDA Clearance of EluPro®: The First Antibiotic-Eluting BioEnvelope Designed to Protect Patients with Implantable Cardiac Pacemakers and Defibrillators
GlobeNewswire News Room· 2024-06-17 12:00
EluPro becomes the only drug-eluting biologic envelope to receive FDA clearance in the $600 million U.S. implantable electronic device protection market EluPro also granted clearance for indications beyond CIEDs, including neurostimulators and neuromodulators used for pain management, epilepsy, incontinence, and sleep apnea SILVER SPRING, Md., June 17, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) ("Elutia" or the "Company"), a pioneer in drug-eluting biomatrix products, today announced that its Antib ...
Elutia(ELUT) - 2024 Q1 - Quarterly Report
2024-05-13 21:01
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-39577 Elutia Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of inco ...
Elutia to Showcase BioEnvelope Product Line at Heart Rhythm 2024
Newsfilter· 2024-05-13 12:00
SILVER SPRING, Md., May 13, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (NASDAQ:ELUT) ("Elutia"), a company pioneering drug-eluting biomatrix products, is excited to announce its participation in the upcoming Heart Rhythm Society's annual meeting (HRS 2024), where it will showcase its innovative CanGaroo® BioEnvelope product line. Designed specifically for cardiac implantable electronic devices (CIEDs), the biologic matrix of the envelope works with the body to promote a natural healing response and enhance device ...
Elutia(ELUT) - 2024 Q1 - Earnings Call Transcript
2024-05-12 16:21
Financial Data and Key Metrics Changes - The company reported net sales of $6.7 million for the quarter, compared to $6.4 million in the first quarter of 2023, indicating growth led by the SimpliDerm product line, which saw a 55% increase [31][70]. - The adjusted gross margin was 55% in Q1, down from 66% a year ago, primarily due to noncash amortization expenses [13]. - Operating expenses were $11.3 million for the quarter, slightly down from $11.7 million a year ago, with $2 million attributed to noncash stock-based compensation [32]. Business Line Data and Key Metrics Changes - SimpliDerm was the standout performer with a 55% growth in sales, while CanGaroo maintained consistent revenue compared to the previous year despite a smaller commercial organization [31][70]. - The company is preparing for the launch of CanGarooRM, which is expected to enter a $600 million market for device protection in pacemakers [92][61]. Market Data and Key Metrics Changes - The breast reconstruction market in the U.S. is approximately a $1.6 billion addressable market, with significant opportunities for innovation [79]. - The pacemaker market has about 500,000 placements annually, with Medtronic holding a 40% market share, and the company aims to disrupt this market with its CanGarooRM product [71][98]. Company Strategy and Development Direction - The company is focused on pioneering drug-eluting biologics, with CanGarooRM expected to provide superior outcomes in the pacemaker space [35][92]. - The strategy includes expanding the commercial infrastructure and preparing for the launch of CanGarooRM, targeting existing customers familiar with the CanGaroo product [100][58]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in receiving FDA clearance for CanGarooRM in June, which is anticipated to be a positive decision [38][61]. - The company is optimistic about the growth trajectory of SimpliDerm and the potential for CanGarooRM to capture market share from existing competitors [30][61]. Other Important Information - The company ended the quarter with $12.6 million in cash, excluding approximately $15 million in warrants that are nearly 100% in the money [108]. - The company is actively preparing for the commercialization of CanGarooRM, including scaling production and training the sales force [63][39]. Q&A Session Summary Question: What is the status of the FDA conversations regarding CanGarooRM? - Management indicated that discussions with the FDA have been positive, and they expect clearance in June [54][61]. Question: What preparations are being made for the commercial launch of CanGarooRM? - The company is investing in expanding its commercial infrastructure and preparing VAC packages for hospitals [20][58]. Question: How does the company view the growth of SimpliDerm moving forward? - Management noted that SimpliDerm has been performing exceptionally well, with a robust growth rate and plans to continue expanding the sales team [30][42]. Question: What is the expected timeline for the VAC process after CanGarooRM approval? - The VAC process is expected to vary, with some centers potentially completing it in as little as a month [49][64].
Elutia(ELUT) - 2024 Q1 - Quarterly Results
2024-05-09 21:26
Exhibit 99.1 · Generated strong revenue growth for proprietary product lines in the first quarter of 2024, led by SimpliDerm net sales increasing 55% compared to the first quarter of 2023 · FDA interactions regarding CanGarooRM, Elutia's antibiotic-eluting biologic envelope, continue to be positive · Addressing the final details for CanGarooRM clearance; anticipate FDA decision in the second quarter of 2024 · Preparing for launch of CanGarooRM in the second half of 2024 First Quarter 2024 Financial Results ...
Elutia to Present at the Planet MicroCap Showcase: VEGAS 2024 on Wednesday, May 1
Newsfilter· 2024-04-24 20:05
SILVER SPRING, Md., April 24, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (NASDAQ:ELUT) ("Elutia"), a company pioneering drug-eluting biomatrix products, today announced that Dr. Randy Mills, President and Chief Executive Officer, and Matt Ferguson, Chief Financial Officer, will present at the Planet MicroCap Showcase: VEGAS 2024 on Wednesday, May 1, 2024, at 3:00 p.m. ET (12:00 p.m. PT). Planet MicroCap Showcase: VEGAS 2024Presentation Date: Wednesday, May 1, 2024Presentation Time: 3:00 p.m. ET (12:00 p.m. PT)Web ...
Elutia(ELUT) - 2023 Q4 - Annual Report
2024-03-10 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2023 or ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For transition period from to Commission File Number: 001-39577 Elutia Inc. (Exact name of registrant as specified in its charter) (Address of principal executive offices and Z ...