This is a summary.
Most cancer patients suffer the deleterious effects of chemo simply because their treatment is systemic, affecting both healthy and malignant tissue, and not local. Because of this, 30% of patients will reduce or entirely stop treatment – and the ones that continue their treatment risk long term side effects due to chemo toxicity. This is unacceptable. BioSapien is changing this with a 3D printed biodegradable drug delivery platform that can delivers chemo directly to cancerous cells, sparing the normal tissues. This novel technology is called MediChip™ and it promises to dramatically improve how patients experience and respond to chemotherapy drugs.
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.
We are preparing for our first in-humans trial of this technology and with your support we will start our clinical trials in 2023.
-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)
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