Hub71 Startup BioSapien Opens First Global Clinical Site for MediChip™

The Hub71 startup is moving its localised chemotherapy platform into Phase I clinical evaluation at Burjeel Cancer Institute, with patient screening scheduled to begin on 23 October 2026.

BioSapien has opened the world’s first clinical site for its MediChip™ platform at Burjeel Cancer Institute in Burjeel Medical City, bringing a new approach to localised chemotherapy closer to first-in-human evaluation in Abu Dhabi. Patient screening for the Phase I trial is scheduled to begin on 23 October 2026. The milestone was announced at the Abu Dhabi Future Health Summit 2026, held at ADNEC Centre Abu Dhabi from 20 to 22 October.

The milestone places a Hub71 startup at the point where years of product development, manufacturing and regulatory work begin to generate clinical evidence. It also shows how Abu Dhabi’s health and life sciences ecosystem can connect an international biotech company with regulators, research partners and clinical infrastructure.

A Localised Approach to Chemotherapy Delivery

MediChip™ is an investigational, 3D-printed biodegradable implant designed to deliver cytotoxic therapy directly at the tumour bed. BioSapien describes the platform as providing controlled local release over 28 days from a single placement. Its agent-agnostic architecture is intended to support different therapeutic payloads across solid-tumour indications.

This local-delivery model is designed to concentrate treatment where it is needed while limiting exposure elsewhere in the body. That goal matters because conventional systemic chemotherapy circulates beyond the tumour and can affect healthy tissue. The Phase I study must now establish how the platform performs in people; its safety and clinical benefit have not yet been proven.

Clinical Evaluation Begins at Burjeel Cancer Institute

The first site is located at Burjeel Cancer Institute within Burjeel Medical City in Abu Dhabi. The Phase I study, named OPTIMISE-REFORM, will evaluate MediChip™-5-FU, which delivers the chemotherapy agent 5-fluorouracil, in people with localised rectal cancer, with an initial focus on safety. It is the first trial of its kind in the Middle East. Opening the site enables the clinical team to begin screening prospective participants against the study’s eligibility criteria.

A site opening is an important operational threshold, but it is distinct from dosing a first patient or reporting a clinical result. Screening, informed consent and clinical assessment come first. Keeping that distinction clear is essential for any investigational therapy, particularly in oncology.

The opening follows regulatory approvals announced by BioSapien in June 2026. It also builds on the company’s clinical collaboration with M42’s IROS, an Abu Dhabi-based contract research organisation supporting the planned oncology study in the UAE. All required regulatory and ethics approvals are in place, and the trial is overseen by an independent review committee of leading US oncology experts. The first patients are expected to enrol shortly after the site opening.

From Manufacturing Readiness to a Patient Site

Moving a biotech platform into a human study requires more than a promising concept. The product must be manufactured to clinical standards, analytical methods must be validated and the trial must secure regulatory and ethics approvals before a site can begin screening.

BioSapien completed its first clinical batch of GMP-grade MediChips in the United States with support from Roswell Park Comprehensive Cancer Center and BA Sciences. The company reported that Roswell Park manufactured the batch in its GMP facility, while BA Sciences supported analytical validation, release testing and stability work. The opening at Burjeel Cancer Institute connects that manufacturing preparation with clinical delivery in Abu Dhabi.

A Hub71 Startup Reaches Clinical Validation

BioSapien joined the Hub71 community through the Access Programme. Its progress reflects the kind of market access that specialist startups need: relationships with government, healthcare institutions, researchers and commercial partners, alongside a base from which to operate in the UAE capital.

For health and life sciences companies, that path is rarely linear. Scientific evidence, quality systems, regulation and clinical operations must advance together. Abu Dhabi offers a setting where those capabilities can meet, helping high-growth ventures move from laboratory development towards responsible clinical evaluation.

BioSapien’s milestone adds to a growing record of startups building from Abu Dhabi to address complex global challenges. The company maintains operations in Abu Dhabi and San Diego, connecting research and manufacturing expertise in the United States with the UAE’s clinical research ecosystem.

What Comes Next for MediChip

The immediate next step is patient screening at Burjeel Cancer Institute. Eligible participants who consent to enrolment will be assessed and monitored under the approved Phase I protocol. The study is expected to produce the first human evidence needed to understand MediChip’s safety profile and guide later clinical development.

For BioSapien, the site opening turns clinical readiness into a live research pathway. For Abu Dhabi, it demonstrates how an enabling regulatory environment, specialist clinical partners and a connected startup community can help an emerging biotechnology reach patients through a controlled, evidence-led process.

Read the BioSapien startup profile and explore more news from the Hub71 community.