Preservation, rehabilitation, and storage of living allogenic heart valves capable of growth and self-repair

This technology is a platform to preserve, rehabilitate, and store living heart valves for the off-the-shelf availability of a heart valve replacement capable of growth and self-repair, thereby overcoming the current standard of multiple reoperations and reinterventions

Unmet Need: There is a lack of living valve replacements with growth and self-repair potential, which can avoid structural valve degeneration (SVD) and the need for reoperation

Current methods to treat valve disease include mechanical and bioprosthetic valves. As these prostheses are not composed of living, growth-capable tissue, they inevitably fail due to calcific and non-calcific SVD, increasing the patient’s risk of morbidity and mortality. There is an urgent clinical need for a valve replacement capable of growth and self-repair, which can obviate the current clinical standard of multiple open-heart surgeries throughout a patient’s lifetime to repair or replace structurally degraded valve prostheses.

The Technology: Living rehabilitated heart valve allografts in long-term storage

This technology enables the long-term ex vivo preservation of living allogenic valves for heart valve transplantation. A valvular bioreactor will individually house the procured allografts in a heart valve preservation solution. The bioreactor’s compact, pumpless design facilitates clinical translation, reduces the risk of cross-contamination, and allows for individual removal and inspection of valvular allografts. Throughout storage, the allografts are rehabilitated with biological and immunomodulatory agents to improve their viability, durability, growth potential, and overall performance. Long-term storage of many valve allografts will generate a “living biobank” in which valve allografts will be available “off-the-shelf” in a variety of sizes for rapid availability at the time of surgery. As such, this technology has the potential to change the paradigm of heart valve replacements in children (growth) and adults (self-repair which prevents structural valve degeneration).

Applications:

• Aortic and pulmonary valve disease treatment
• Living allograft tissue bank
• Long-term preservation of tissues and organs
• Treatment and prevention of rapid allograft failure in multiple tissue types
• Anti-immunogenic and anti-antigenic post-transplant therapy
• Heart valve disease research model

Advantages:

• Living valve capable of growth and self-repair
• Off-the-shelf availability
• Increased donor pool for valve availability
• Cost-effective
• Reduced risk of contamination
• High reproducibility
• Rapid access

Lead Inventors:

David Kalfa, M.D., Ph.D.

Gordana Vunjak-Novakovic, Ph.D.

Elizabeth M. Cordoves

Patent Information:

Related Publications:

• LaSala VR, Cordoves EM, Kalfa DM. “Adaptation of cold preservation techniques to partial heart transplant.” J Thorac Cardiovasc Surg. 2024 Aug 22:S0022-5223(24)00697-4.

• Kalfa D, Rajab TK, Cordoves EM, Emani S, Bacha E, Jaggers J, Goldstone A, Eghtesady P, Turek J. “Living allogenic heart valve transplantation: Relative advantages and unanswered questions.” J Thorac Cardiovasc Surg. 2023 Sep 22:S0022-5223(23)00861-9

• Cordoves EM, Ferrari G, Zorn E, Bacha E, Vunjak-Novakovic G, Kalfa D. “Storage, preservation, and rehabilitation of living heart valves to treat congenital heart disease.” Med. 2024;5(8):859-862.

• Kalfa DM, Richmond M, Cordoves EM, Lee T, Zuckerman W, Juergensen S, Shah A, Bacha EA, Goldstone AB. “Domino Heart Valve Transplant in Children with Congenital Valve Disease: Short-Term Outcomes, Growth, and Immunosensitization.” J Am Coll Cardio. 2025 Mar 4; 85(8): 866-869.

• Overbey DM, Aykut B, Kucera JA, Medina CK, Sethi NJ, Barker PCA, Shea EV, Turek JW. “Partial Heart Transplant for Congenital Heart Disease.” JAMA. 2025 Aug 27. Online ahead of print.

Tech Ventures Reference:

• IR CU23223

• Licensing Contact: Kristin Neuman