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Development of a LystaMab coated pericardial adhesion barrier

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HL152844-01
Agency Tracking Number: R43HL152844
Amount: $308,896.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA19-272
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-09-22
Award End Date (Contract End Date): 2021-08-31
Small Business Information
Columbus, OH 43212-1180
United States
DUNS: 079811792
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (207) 513-7020
Business Contact
Phone: (216) 374-4502
Research Institution

Despite significant advances in the surgical and medical management of congenital heart disease, congenital
cardiac anomalies remain a leading cause of death in the newborn period. Most severe forms of congenital
heart disease require multiple, staged surgical interventions. A significant source of the heightened morbidity
and mortality associated with these operations is the development of cardiac adhesions. Adhesions are
fibrous bands of scar tissue that connect two areas of the body not normally connected and arise due to
unavoidable surgical trauma. Adhesions are exacerbated by excessive inflammation in the post-operative
period. Dissection of adhesions significantly complicate reoperation by increasing operative and anesthetic
time and amplifying the risks of perioperative bleeding and iatrogenic injury to the heart and great vessels,
which are all associated with worse outcomes and increased cost. Currently there are no FDA approved
products that reduce the incidence of the complications associated with reoperation in congenital heart surgery.
We recently discovered that the LYST protein underlies the development of dense adhesions after
cardiothoracic surgery and hypothesize that rational inhibition of LYST will attenuate excessive inflammation
following surgery, thereby preventing adhesions formation. A top priority for the LYST Therapeutics is to derisk
the use of anti-LYST therapy to inhibit the formation of adhesions after cardiac surgery. In this proposal, we
will investigate the use of local delivery of LystaMab (a monoclonal anti-Lyst antibody) to optimize its safety
and efficacy for preventing pericardial adhesions. The successful development of anti-LYST therapy to mitigate
the development of cardiac adhesions would represent a novel form of rationally designed immunomodulation
that could significantly improve outcomes in the pediatric congenital hear population. Development of safe and
effective strategy to prevent the formation of cardiac adhesions would significantly benefit children born with
congenital heart defects requiring multiple surgeries and would overcome a major barrier to progress in the
field of congenital heart surgery.NARRATIVE
Congenital cardiac anomalies are the most common birth defect and a leading cause of death in the newborn
period. Severe forms of congenital cardiac anomalies require multiple reconstructive surgeries. Unfortunately,
complications arising from the development of adhesions are a significant cause of postoperative morbidity and
mortality. The development and translation of a safe and effective strategy to prevent the development of
cardiac adhesions without adversely effecting wound healing holds great promise for advancing the field of
congenital heart surgery and improving outcomes of infants requiring repeat surgical intervention.

* Information listed above is at the time of submission. *

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