Harvard Apparatus Regenerative Technology, Inc. (HART) Revolutionizing Implantation through Development of Second-Generation Implant Platform

Harvard Apparatus Regenerative Technology is a biotechnology company developing bioengineered organs in order to better address a collection of life-threatening conditions. The company’s development pipeline is headlined by its proprietary second-generation bioengineered organ implant platform, which is currently being developed as a tool to guide the repair of a patient’s own tissue in three unique indications – including diseases of the trachea, bronchi and esophagus. By utilizing a multi-platform approach to clinical development, HART intends to dramatically expand its market opportunity as it continues to explore the development and regulatory pathways for each indication in the coming months.

In recent months, HART’s scientific efforts have been primarily focused on targeting the body response issues encountered during testing of its first-generation trachea product. The company addressed these concerns by utilizing a more elastic material for the device’s scaffold and changing the type of cell that’s seeded onto the scaffold prior to implementation. Through these modifications, HART anticipates achieving improved regenerative response from the body, as well as a more natural restoration of organ function than was observed from its first-generation product. The company, in partnership with the Mayo Clinic, will put these hypotheses to the test in preclinical studies examining its second-generation platform during the fourth quarter of this year.

“We have made tremendous progress in recent months with the development of our second-generation bioengineered organ implant products,” Jim McGorry, chief executive officer of HART, stated in an August news release. “We are poised to make significant further progress over the coming 18 months, including key preclinical and regulatory achievements.”

As of June 30, the company reported a strong cash balance of $10.1 million with no outstanding debt. This favorable balance sheet is expected to play an instrumental role in HART’s ongoing efforts to develop and commercialize its innovative organ implant platform. In order to streamline this progress, the company has built a dedicated internal team of material scientists, engineers and biologists who, in collaboration with the Mayo Clinic and Connecticut Children’s Medical Center, are focused on bringing its products to the patients who need them as quickly as possible.

Currently, most human organs that are surgically implanted come from donors, creating a debilitating market shortage that costs the lives of an average of 22 people in the United States each day, according to the U.S. Department of Health and Human Services. Additionally, immunosuppression following these transplants – which is necessary to insure that the implanted organ isn’t rejected – can lead to serious, potentially deadly infections. By utilizing a patient’s own cells to produce bioengineered organs, HART’s second-generation platform could effectively address both of these limiting factors, allowing the company to establish a sustainable foothold in some of the medical industry’s most critically underserved indications in the near future.

For more information, visit www.harvardapparatusregen.com

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