A 3D Printed Biodegradable Chip Delivers Chemo Locally Saving Patients from Chemo-Related Toxicity

What is the critical gap in cancer treatment that you are addressing?

The standard of care for most cancers almost always involves systemic chemotherapy, which means the whole body is impacted by chemo whether there is cancer there or not. This is a serious problem for patients because chemotherapy can destroy healthy tissues as well as cancerous tissue. Over 80% of patients who receive chemotherapy report at least one side-effect during treatment. More than 27% report serious side effects. Over 30% of those patients with side effects will reduce or stop chemotherapy due to this problem. With this systemic treatment we are essentially poisoning the entire body to get at cancerous tissue because we lack the ability to localize this very toxic therapy. This practice has been going on since the 1960’s when the first chemo cocktails were considered state of the art. We believe today’s cancer treatments can be more localized, less toxic and offer better outcomes.

BioSapien’s motto is: treating cancer locally. Our goal is to change the way cancer care is delivered to be focused and preserve as much healthy tissue as possible. BioSapien has developed a localized drug delivery platform that is designed to be placed directly on the tumor and releases one or more drugs like chemotherapies. The MediChip™ is placed directly onto the tumor and sutured into place and will deliver drugs onto the tumor for one to three months, after which it will be removed. The intention is to reduce serious systemic side effects and to increase local penetration of these highly toxic medications. While in place, the drugs are released over one to three months in a controlled manner, meaning fewer office visits are required during therapy.  Our solution has potential to improve patient outcomes and provide better access to care for those who may not live near a center of excellence or be able to take time off work for the weekly chemotherapy treatment. We would also expect that without chemotherapy systemic side effects there would be fewer Emergency and Hospital visits associated with those treatments, which would also reduce hospital and insurance burden.

BioSapien’s lead product is a 3D printed biodegradable drug delivery platform that delivers FDA-approved chemotherapy drugs directly to cancerous cells. This novel technology is called MediChip™. Our manufacturing process produces this product in a 3D printer which builds the MediChip™ layer by layer, allowing us to control its dosage form. The extended release property provides for sustained localized release of chemotherapy directly onto the tumor. The product is made from materials that will break down into non-toxic substances and be eliminated from the body.

What is the key product development milestone you seek to fund?

We are preparing for our first in-humans trial of this technology and with your support we will start our clinical trials in 2023.

How will funds be used?

-Produce experimental and clinical batch of MediChip™-5-FU, ready for commercial scale production. ($855,000)

-Large Animal Toxicology Study to enable human trial ($900,000)

-First-in-humans Phase 1A/2B with 6 patients dosed ($330,000)

-Additional sapiens to join the mission with executive experience and expansion of C-suite (CFO/CBO, Head of Partnerships), CSO and an established clinical team ($750,000)

What key resources have/will you acquire to facilitate the accomplishment of the above product development milestone?

We have a small but dedicated team of physicians, scientists, and regulatory affairs veterans who have all agreed that the status quo of cancer treatment is not sufficient. What we need to move this project forward is funding to help build out our manufacturing capabilities, produce GMP products, and complete our GLP enabling toxicology studies to enable our IND application to the FDA.

We have received and completed a Phase 1 National Science Foundation grant for our technology. We intend to apply for a Phase 2 $1 Million+ grant to continue to develop this technology. More recently we won 1st place at the Louisiana Start-up Prize competition for the Focus on Health FDA Track.

If your Technology were to disappear in the “Valley of Death” funding bottleneck how might this impact society?

There are 1.8 Million new cancer cases each year in America alone. Most of whom will receive systemic chemotherapy. Hundreds of thousands of these patients will suffer from the serious side effects of systemic chemotherapy. Most people know about  hair loss, nausea and vomiting. But there are many more side effects, including chemo brain (loss of concentration and focus), constipation or diarrhea, changes in mood, nerve damage leading to numbness and pain, reduction in blood cell counts which can increase risks of infections and much more.MediChip™ could change this calculus by removing systemic side effects. Chemotherapy delivery has not changed since the 1960s and it is well past time we utilize modern technologies like 3D printing to repackage and deliver these chemotherapies

Press Release:

The Female Founders of MicroVentures’ Portfolio

MediChip Aims to Deliver Localized Cancer Treatment

Published Patents:

Biovessels For Use In Tissue Engineering

Drug-eluting Surgical Articles And Related Methods

Khatija Ali, MD

Chief Executive Officer

Khatija Ali is the CEO & founder of BioSapien. Khatija is the inventor of the MediChip. She has successfully raised capital totaling $2.5M for MediChip, backed by SOSV, Hikma, Side Door Ventures and other VCs. She has 3+ years of venture capital experience with launching companies and assets within life science. As a Venture Fellow for HIC, the first pediatric oncology impact fund, Khatija helped with fund formation and capital raise for $100M. In addition, Khatija has 2+ years of experience in building and launching companies at HB. Skilled with medicine and powered by the logic of philosophy, she aims to provide patients with new and innovative products.

Sonia Ramamoorthy MD MBA FACS

Chief Medical Officer

Academic health system physician leader with 20 years of experience in a matrixed academic medical center. Nationally recognized GI cancer surgeon with experience in program building, clinical innovation, and organizational strategy. Diverse background in quality and safety, physician governance, and high performing team management. Champion of diversity, equity and inclusion who has implemented positive change through cultural transformation, education, and awareness.

Anil Dosaj, MD

Head of Operations

Anil Dosaj is the Head of Operations at BioSapien. He has previously built and managed a 10 site clinical trial network. He has a background in Business Administration, Chemistry, the Medical Laboratory and Informatics. He has also been on the Data Management Committee and a NeuroInformatics Lead at the Ontario Brain Institute.

Martin Krusin MBA

Chief Financial Officer

Martin has 20+ years of business development, marketing, finance, operations and general management experience in healthcare and financial services. Significant experience in due diligence, risk management, and M&A across multiple sectors, including biotech, biopharma, and medtech.

Anne Phan, PhD