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Harvard Apparatus Regenerative: Hart Reports Q3 Financial Results And Provides Business Update

The following excerpt is from the company's SEC filing.

- Conference call today at 5:00 p.m. ET -

- Harvard Apparatus Regenerative Technology, Inc. (HART) (Nasdaq: HART), a biotechnology company developing bioengineered organ implants for life-threatening conditions, today reported third quarter financial results and provided a business update. Separately this morning, HART reported significant results from research involving its second-generation (Gen2) bioengineered trachea, bronchus and esophagus implants in large animals

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HART will host a conference call today at 5:00 pm ET to revie w its results, progress and outlook (details below).

Business Update

HART has made solid advances towards key objectives during the past several months.

Most notably, as announced earlier today, the company has made significant advances in the development of its Gen2 bioengineered implants. HART’s Gen2 technology reflects design enhancements to improve the body’s response to the implant and to better guide the repair of tissue in the healing process. The Company’s recent animal studies tested all three of its Gen2 implants – esophagus, trachea, and bronchus – demonstrating resolution of the negative inflammatory response observed with the prior generation of the technology. Clinically significant evidence of tissue and nerve regeneration was observed in the esophageal implant, positioning the esophageal implant as the current lead development priority.

Importantly, HART’s esophageal implant is intended to address a very significant need as a potentially life-saving treatment for patients with esophageal cancer. Each year in the U.S. a

pproximately 17,000 new cases of

sophageal cancer are diagnosed, and more than 4,000 are addressed by surgery.

The Company believes that these results underscore the value and potential of its platform technology to treat these patients and pave the way for further studies and its regulatory pathway for human clinical trials.

The company also continued to advance its development partnerships, specifically collaborations with Mayo Clinic and Connecticut Children’s Medical Center (CCMC). HART’s collaboration with Mayo Clinic focuses on developing solutions for cancer and other life-threatening diseases affecting the esophagus, bronchus and trachea. HART has initiated its planned confirmatory large-animal studies of its Gen2 implants in collaboration with Mayo Clinic. The study design has been completed, prerequisite tests are underway and the Company expects the animal surgeries to occur in December. The Company’s collaboration with CCMC is focused on developing a solution for a congenital childhood condition, pediatric esophageal atresia, a condition in which a significant or complete separation of a child’s esophagus prevents normal eating function. Initial tests with CCMC commenced during the third quarter.

Recent Highlights:

HART Reports Significant Results for 2nd Generation Bioengineered Implants

Dr. Joseph Vacanti to Chair New Scientific Advisory Board

Pre-clinical Collaboration with Connecticut Children's Medical Center

Dr. Saverio La Francesca Promoted to EVP and Chief Medical Officer

HART CEO, Jim McGorry, commented, “We made significant...


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