Duyuru • Apr 29
Harvard Apparatus Regenerative Technology Announces First Patient Treated with Cellspan Esophageal Implant At Mayo Clinic Harvard Apparatus Regenerative Technology Inc. announced that the first patient has been treated with its Cellspan Esophageal Implant (CEI) in the Company’s Phase 1 feasibility and safety clinical trial conducted at the Mayo Clinic in Rochester, Minnesota. Life-Threatening esophageal disease, including severe strictures, represents a significant unmet medical need. Current treatment options are limited and often involve highly invasive procedures with substantial morbidity. The Cellspan Esophageal Implant is designed to leverage the patient’s own regenerative capacity, offering a potential alternative to conventional surgical reconstruction. The Company’s Phase 1 clinical trial is a feasibility and safety study in up to ten patients under an FDA-approved IND. We activated three clinical trial sites, the Mayo Clinic, the University of Michigan Medical Center and the University of Southern California in Los Angeles. The primary endpoint of the ongoing trial is the establishment of a continuous biological neoconduit, or tube, by three months post-surgery. One of the secondary endpoints will be the development of a mucosal lining in the esophagus by twelve months post-surgery. CellSpan Esophageal Implant (CEI) is a combination product. It consists of a modified polyurethane tubular CellFrame mesh scaffold with direct delivery of live autologous adipose derived Mesenchymal Stromal Cells to the esophagus. The CEI provides temporary support during the initial tissue growth phase, and the scaffold is removed endoscopically at 21–42 days post implant. The Company extends its sincere appreciation to IQVIA Biotech for their exceptional project management, site activation support, and cross-functional coordination throughout this Phase 1 clinical trial. From study start-up through first patient treatment, IQVIA Biotech's dedicated team ensured seamless site readiness, protocol adherence, and operational execution, playing an integral role in bringing this clinical milestone to completion on time and to the highest standards of quality. Harvard Apparatus Regenerative Technology also extends its deepest appreciation to the entire clinical and research team at the Mayo Clinic for their professionalism, dedication, and collaborative spirit in bringing this milestone to fruition. The Company looks forward to continuing this important partnership as the program advances. We conducted the world’s first successful regeneration of the esophagus in a patient with esophageal cancer in August 2017. This surgery was performed by Dr. Dennis Wigle, Chair of Thoracic Surgery at the Mayo Clinic. The results were published in the Journal of Thoracic Oncology Clinical and Research Reports in August 2021. HRGN has 13 issued U.S. patents, 2 issued in China, 1 issued in Japan, 2 issued in Europe, 2 U.S. orphan-drug designations which can provide seven years of market exclusivity in the US market after market approval from the FDA and 1 EMA orphan drug designation, which can provide ten years of market exclusivity in the European market after market approval from the EMA. Duyuru • Apr 24
Harvard Apparatus Regenerative Technology Inc., Annual General Meeting, Jun 18, 2026 Harvard Apparatus Regenerative Technology Inc., Annual General Meeting, Jun 18, 2026. Location: at 84 october hill road, suite 11, ma 01746., holliston United States Duyuru • Apr 18
Harvard Apparatus Regenerative Technology Inc., Annual General Meeting, Jun 20, 2025 Harvard Apparatus Regenerative Technology Inc., Annual General Meeting, Jun 20, 2025. Location: 84 october hill road, suite 11, holliston, ma 01746., United States Duyuru • Aug 07
Harvard Apparatus Regenerative Technology Inc. announced that it has received $1.482101 million in funding On August 6, 2024, Harvard Apparatus Regenerative Technology Inc. closed the transaction. Duyuru • May 01
Harvard Apparatus Regenerative Technology Inc., Annual General Meeting, Jun 20, 2024 Harvard Apparatus Regenerative Technology Inc., Annual General Meeting, Jun 20, 2024, at 09:30 Eastern Daylight. Location: 84 October Hill Road, Suite 11, 01746 Holliston Massachusetts United States Agenda: To elect three Director nominees as Class II Directors, nominated by the Board of Directors for a three-year term, such term to continue until the annual meeting of stockholders in 2027 and until such Director’s successor is duly elected and qualified, or until his resignation or removal; to ratify the appointment of Marcum LLP as independent registered public accounting firm for the fiscal year ending December 31, 2024; to consider and vote, on a non-binding advisory basis, as to the approval of the compensation of named executive officers as disclosed in this proxy statement; and to consider and vote upon such other business as may properly come before the Annual Meeting and any adjournments or postponements thereof. Duyuru • Nov 10
Harvard Apparatus Regenerative Technology Inc. to Report Q3, 2023 Results on Nov 13, 2023 Harvard Apparatus Regenerative Technology Inc. announced that they will report Q3, 2023 results on Nov 13, 2023 Duyuru • Aug 10
Harvard Apparatus Regenerative Technology Inc. to Report Q2, 2023 Results on Aug 14, 2023 Harvard Apparatus Regenerative Technology Inc. announced that they will report Q2, 2023 results on Aug 14, 2023 Duyuru • Jul 21
Biostage, Inc. Activated Mayo Clinic as the First Site for Clinical Trial in Severe Esophageal Disease Biostage, Inc. announced that it officially activated the site with Mayo Clinic for its clinical trial as to severe esophageal disease, being its first clinical trial in the United States. The Phase 1, first-in-human study approved by the FDA will evaluate both safety and efficacy in up to ten patients requiring the removal of up to 6 cm of their esophagus (including cancer, trauma or birth defects) at up to five hospitals in the U.S. The primary endpoint is the development of a continuous biological neo-conduit at three months following implantation. Duyuru • Jun 06
Biostage, Inc., Annual General Meeting, Jul 19, 2023 Biostage, Inc., Annual General Meeting, Jul 19, 2023, at 09:30 Eastern Daylight. Location: 84 October Hill Road, Suite 11 Holliston Massachusetts United States Agenda: To consider election of directors; to ratify the appointment of Marcum LLP as independent registered public accounting firm for the fiscal year ending December 31, 2023; to approve an amendment to Amended and Restated Equity Incentive Plan to increase the number of shares of common stock available for issuance pursuant thereto; to consider and vote, on a non-binding advisory basis, as to the approval of the compensation of named executive officers as disclosed in the proxy statement; and to consider and vote upon such other business as may properly come before the Annual Meeting and any adjournments or postponements thereof. Duyuru • Jan 13
Biostage, Inc. Amends CEO Employment Agreement Biostage, Inc. announced that effective as of January 11, 2023, Biostage, Inc. (the Company) entered into an Amended and Restated Employment Agreement (the Amended Agreement) with David Green, the Chief Executive Officer of the Company, to remove the Interim designation from his Chief Executive Officer title effective immediately, and also amend certain terms of Mr. Green's existing Employment Agreement. Duyuru • Dec 24
Biostage, Inc. Announces New Publication Demonstrates Rapid Esophageal Regeneration Using the Biostage Esophageal Implant Biostage, Inc. announced the publication of a paper in the peer-reviewed Journal of Immunology and Regenerative Medicine that describes the early tissue growth and regeneration processes following the implantation of the Biostage Esophageal Implant (BEI) in nine pigs with full circumferential esophageal segmental replacement. The BEI stimulated new blood vessel growth and all animals regenerated a continuous biological conduit by 28 days. The regeneration time period as noted in the paper compares favorably with the primary endpoint of Biostage's FDA-approved clinical trial which is to show a continuous biological conduit by 90 days. Biostage expects to initiate patient recruitment in its first clinical trial in early 2023. The Biostage Esophageal Implant (previously known as Cellspan Esophageal Implant) stimulates the regeneration of new tissue to repair the esophagus following a full circumferential segmental resection. The paper in the Journal of Immunology and Regenerative Medicine describes a study that investigated the early growth and tissue composition of the newly developed tissue as well as the fate of the adipose derived mesenchymal stromal cells (Ad-MSC) that are seeded onto the scaffold prior to implantation. The BEI bridged the esophageal ends and restored the conduit by stimulating a regeneration process that includes rapid neovascularization followed by mucosal regeneration that was quantified from day 14 to day 28 post-implantation. Duyuru • Nov 11
Biostage, Inc. to Report Q3, 2022 Results on Nov 14, 2022 Biostage, Inc. announced that they will report Q3, 2022 results on Nov 14, 2022 Duyuru • Aug 09
Biostage, Inc. Announces Appointment of Joseph Damasio as New Chief Financial Officer Biostage, Inc. announced the appointment of Joseph Damasio as the company's new Chief Financial Officer. Joe provides Biostage with considerable experience in raising capital and running operations for small-cap biotech companies. Recently his experience has included CFO, VP Finance and Controller roles at: Inhibikase Therapeutics, Cue Biopharma and Pressure Biosciences. He has managed multiple capital raises, both private and public, including uplisting to NASDAQ. Joe holds a BS in Accounting from the University of Massachusetts (Dartmouth), an MS in Finance from Boston College and an MBA from Boston College. He is a Massachusetts-licensed CPA, a former auditor with PriceWaterhouseCoopers and formerly served in the U.S. Navy. Duyuru • Aug 05
Biostage, Inc. to Report Q2, 2022 Results on Aug 04, 2022 Biostage, Inc. announced that they will report Q2, 2022 results at 4:00 PM, US Eastern Standard Time on Aug 04, 2022 Duyuru • Jun 16
Biostage, Inc. Announces Publication of Mechanical Strength Data for Regenerated Esophageal Tissue in Journal of Biomechanics Biostage, Inc. announced the publication of a paper in the peer-reviewed Journal of Biomechanics, describing a study investigating the mechanical strength of regenerated esophageal tissues. The Biostage Esophageal Implant (previously known as Cellspan Esophageal Implant) stimulates the regeneration of new tissue to repair the esophagus following segmental resection of the thoracic esophagus. Using a porcine model, the paper in the Journal of Biomechanics describes a study that tested the mechanical strength of the newly developed tissue as well as the flanking native tissue using a probe-burst pressure test on explanted tissues at three time points post-implantation. The BEI bridged the proximal and distal native esophageal ends to restore the conduit by stimulating a regeneration process that progressed from a fibrovascular scar at 30-days to a fully epithelialized lumen at 90-days, followed by submucosal regeneration and regeneration of a 'laminated' adventitia with smooth muscle development in the 365-day cohort. The burst strength of the regenerated tissues at all three time points were comparable to the native tissue flanking the implant and the overall pressure required to burst through the tissue increased with increasing time post-surgery. Duyuru • May 18
Biostage, Inc. announced that it has received $5.060244 million in funding On May 16, 2022, Biostage, Inc. closed the transaction. The company issued 43,960 units for gross proceeds of $260,000 in its second and final tranche bringing the total gross proceeds raised in the transaction to $5,060,244.32. Duyuru • May 14
Biostage, Inc. Announces $5.1 Million Financing to Advance Clinical Trial Biostage, Inc. announced that it has raised approximately $5.1 million from new and existing investors in a private placement of its shares. Additional details are provided below. The funds will be used to accelerate the clinical development of Biostage's lead product candidate, the Biostage Esophageal Implant, or BEI. The FDA has approved a ten-patient phase one and phase two clinical trial to study the repair of damage to the esophagus in adults caused by cancer or injury. The FDA has indicated a willingness to consider expanding this clinical trial to include pediatric subjects with birth defects in the esophagus once the safety of the implant is shown in adults. Hence, the Company expects the repair of birth defects in the esophagus to be an additional indication for which Biostage will seek FDA approval. Biostage is also developing other uses of its technology such as for treating cancer of the lung using the Biostage Bronchial Implant. Similar to how the BEI could be used to regenerate the esophagus, the Biostage Bronchial Implant would be used to regenerate a bronchus that has been surgically removed to treat bronchial cancer, injury or birth defects. Duyuru • May 12
Biostage, Inc. to Report Q1, 2022 Results on May 16, 2022 Biostage, Inc. announced that they will report Q1, 2022 results on May 16, 2022 Duyuru • May 03
Biostage, Inc., Annual General Meeting, Jun 22, 2022 Biostage, Inc., Annual General Meeting, Jun 22, 2022, at 08:00 Eastern Daylight. Agenda: To elect two Director nominees as Class III Directors, nominated by the Board of Directors for a three-year term, such term to continue until the annual meeting of stockholders in 2025 and until such Director’s successor is duly elected and qualified or until her earlier resignation or removal; to consider and vote, on a non-binding advisory basis, as to the approval of the compensation of the company's named executive officers; to consider and vote, on a non-binding advisory basis, as to the frequency of future advisory votes on the compensation of the company's named executive officers; and to consider and vote upon such other business as may properly come before the Annual Meeting and any adjournments or postponements thereof. Duyuru • Jan 26
Biostage Announces Court's Preliminary Injunction Order Requiring Its Insurance Carrier to Continue Paying for Defense Biostage, Inc. announced that a Court has ordered that its medical liability insurance carrier, Medmarc, breached its duty to defend the Company when Medmarc unilaterally stopped paying Biostage's legal bills for the defense in the litigation from the estate of a patient who died after being treated with a Biostage Tracheal Implant. In September 2021, Medmarc filed a lawsuit seeking to be relieved of its duty to defend and indemnify Biostage in the litigation. At that time, Medmarc stopped paying the Company's defense costs in the litigation. Biostage responded by filing claims against Medmarc for insurance coverage, and Biostage also brought a motion seeking the Court to Order Medmarc to continue paying for the Company's reasonable defense costs in the underlying litigation while the coverage dispute is pending. The Court granted Biostage's motion for preliminary injunction and held that Medmarc breached its duty to defend the Company when it unilaterally stopped paying for the defense. The Court expressly stated that Medmarc engaged in "unlawful conduct" by unilaterally terminating the defense. Although the coverage dispute remains pending between the parties, the Court held that "Medmarc will mostly likely lose its claim" seeking to terminate the payment of the defense, and therefore, it must continue to pay the defense until the coverage dispute is resolved. The Court also awarded Biostage its attorneys' fees and costs arising from Medmarc's breach of the duty to defend. The Court's decision states that "when an insured goes to court and shows that the insurer has breached its duty to defend, the insured is entitled to recovery any reasonable attorneys' fees and other litigation expenses that it incurred to do so." Biostage has since discontinued development of the Biostage Tracheal Implant and is now pursuing the development of the Biostage Esophageal Implant to treat adults with severe esophageal disease (including esophageal cancer), and also birth defects in the esophagus in babies. Duyuru • Jan 12
Biostage Announces Publication of Paper Establishing the Basis for Using its Product to Treat Birth Defects in the Esophagus in Babies Biostage, Inc. announced the publication of paper establishing the basis for using its product to treat birth defects in the esophagus in babies. The piglets gained weight steadily over the course of the study and eventually tripled their size, showing that the regenerated esophagus grows with the patient. The paper states that current techniques for repairing birth defects in the esophagus, "have significant costs, complication rates, lengthy hospital stays, and significant morbidities. Therefore, the development of novel approaches that bridge a primary long gap…are highly desired." Dr. Christine Finck, Surgeon in Chief, Connecticut Children's Medical Center, who performed the surgeries, said "this technology has the potential to provide a novel therapy for some of their must fragile patients." Biostage has previously reported on the first-in-human regeneration of an esophagus in an adult cancer patient, performed at Mayo Clinic and published in JTO Clinical and Research Reports in August 2021. That paper concluded that the Biostage Esophageal Implant would have, "considerable clinical use." The FDA has already approved a 10-patient, phase 1/2 clinical trial for repair of the esophagus in adults. The FDA has indicated a willingness to consider expanding the current clinical trial to include pediatric subjects once the safety of the implant is shown in adults. Hence, they expect the repair of birth defects in the esophagus to be an additional indication for which Biostage will seek FDA approval. Duyuru • May 18
Biostage, Inc. announced delayed 10-Q filing On 05/17/2021, Biostage, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Duyuru • Apr 02
Biostage, Inc. announced delayed annual 10-K filing On 03/31/2021, Biostage, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Duyuru • Feb 05
Biostage, Inc. Announces Resignation of James Mastridge as Interim Vice President of Finance or Principal Accounting and Financial Officer On January 29, 2021, Danforth Advisors, LLC (“Danforth”) notified Biostage, Inc. (the “Company”), that Danforth was terminating its Consulting Agreement with the Company. As a result and effective as of such termination, James Mastridge, is no longer serving as the Company’s interim Vice President of Finance or principal accounting and financial officer. The Company is actively in the process of identifying a qualified candidate to serve as the Company’s principal accounting and financial officer. Duyuru • Jan 26
Biostage, Inc. Appoints Herman Sanchez as an Independent Director Biostage, Inc. announced that it appointed Herman Sanchez as an independent director to its Board of Directors. Mr. Sanchez has been working in the life sciences industry for over 20 years in various positions including designing and running randomized trial research, optimizing of clinical administration of health services, and working as a strategic consultant to the life sciences industry. He is currently a Senior Partner helping run Trinity Life Sciences’ strategy consulting business. He joined Trinity over a decade ago and has worked closely with clients to support strategic decision making across the product lifecycle. In his work consulting for pharmaceutical/biotech and medical device companies he has covered several diseases/therapeutic areas including oncology, rare and ultra-rare diseases, cell therapies, cardiovascular, diabetes, alcohol abuse/dependence, neurological, orthopedic, and renal diseases. He has been published in peer-reviewed publications on various topics including renal disease, patient epidemiology, medication adherence, suicidal ideation, minority patient recruiting, alcohol use/abuse and depression/anxiety treatment. Mr. Sanchez, prior to working in the life sciences industry, earned an MBA from the Tuck School of Business at Dartmouth and an AB in Psychology from Harvard University.