On their website, the National Science Foundation’s Innovation Corps (I-Corps™) states that their program “uses experiential education to help researchers gain valuable insight into entrepreneurship, starting a business or industry requirements and challenges. I-Corps enables the transformation of invention to impact”. The BioSuperior team were excited to be part of the program, as a result of the NSF I-Corps grant they were awarded in 2019 (award #1917312).

“When we joined the NSF I-Corps program, we knew we would get valuable insight. It brought to light a critical and urgent need we vowed to meet”, said Russ Lehrman, BioSuperior CEO and Founder.

Coming into the program, the team’s goal was to deepen their understanding of the market needs and readiness for a novel synthetic lung surfactant for use in premature infants and adults suffering from Acute Lung Injury. Respiratory diseases represent the fourth leading cause of death in the US and yet there is no cure for many of these diseases today, despite decades of research.

The team (Russ, together with Ehud Goldin, PhD and Lucia Mokres, DVM) ran a study in which they conducted more than 100 interviews with industry experts, including clinicians, nurses, hospital administrators and payor consultants. The feedback they got was invaluable, confirming key assumptions and bringing some to the forefront. “It is important to constantly challenge one’s thinking in order to succeed. The I-Corps program really helps facilitate that process”, said Lucia.

At the study’s outset, the team posited that delivering a synthetic lung surfactant would be a more cost-effective, easily accessible and non-invasive alternative to the current animal-based surfactants in the fight against lung disease. However, talking with clinicians highlighted the more important and unique value their synthetic surfactant had over animal-based ones: the ability to serve as a drug platform to deliver therapeutics directly into the lungs. While the team knew this was an important capability, they realized how transformational it could be in curing lung disease and other illnesses. It became a top priority in shaping the company’s direction and product strategy.

Today, lung surfactant treatments are extracted from animal lungs. These products have improved the standard of care for patients with breathing problems, but do not reduce inflammation or address other critical inflammation issues suffered by pre-term babies with Bronchopulmonary Dysplasia (BPD) and adults with Acute Lung Injury (ALI). This is an urgent unmet medical need that BioSuperior can address using it’s technology.

Serving as a drug platform, the BioSuperior synthetic surfactant, BioSURF™, can deliver anti-inflammatory therapeutics directly and rapidly into the lung to target affected areas at the time when inflammation develops, and help restore lung function. It can also enable additional drugs to be delivered into the lungs of injured patients and can ultimately be used beyond lung disease.

The synthetic lung surfactant can be administered to preterm infants in the same way animal-derived products are being administered. No specialized training or process change is required for clinicians already treating lung disease with animal-derived products. This is an important criterion in ensuring market acceptance.

While the platform need was undoubtedly the most important take away from the study, other key insights helped refine the team’s product development strategy. Understanding how a product will be used in the field is extremely important to ensure it will meet its intended need. To that end, speaking to Neonatal Intensive Care Unit (NICU) nurses was eye opening.

NICU nurses are on the front line with patients. Their feedback helped Russ, Lucia and Ehud understand what is currently missing in the field. For instance, pre-term babies are so small they need to be held in a certain way when therapeutics are being delivered to avoid inflammation and lifelong consequences.  This information is very valuable in designing a product that will ensure the safest instillation of surfactant into lungs.

Another important element to consider in the development of lung surfactant is the dosage required to effectively treat a patient. The nurses’ feedback confirmed that today’s dosage for animal-based surfactants is tough on small babies. BioSuperior’s product will require smaller dosage, which will help avoid complications during instillation. This means babies will be able to withstand their treatments better and heal faster.

A shorter treatment time means these infants will be able to reunite more quickly with their mothers, reinforcing a connection that is critical for their development. A shorter treatment also means a significant decrease in the overall cost of hospitalization. Treating lung disease is expensive for families, hospitals and the government, reaching hundreds of thousands of dollars in certain cases. The scale and costs of lung disease have soared exponentially over the last few years, further bolstered by the recent emergence of COVID. Delivering the right therapeutics is more critical now than ever.

The BioSuperior team gathered valuable insight as part of the NSF I-Corps program. It helped them validate key assumptions and narrow down their priorities to focus on those that are most critical to the market and where BioSuperior has a clear advantage to succeed. As Ehud shared, “This is an iterative process and we are keeping an open mind. There are many things in science that are not documented and that come down to experience”. The team is continuously talking to industry experts, leveraging their collective experience to help refine the company direction and deliver on its mission to revolutionize pulmonary care and save lives by curing lung disease.