Alcresta Therapeutics, Inc.
Alcresta develops novel enzyme-based products that improve nutritional care for patients living with rare diseases. With a focus on enzyme products designed for enteral nutrition, the company aims to address unmet needs in fat malabsorption conditions such as cystic fibrosis, pancreatitis, and short bowel syndrome. Backed by top-tier venture investors, Alcresta leverages its proprietary platform and extensive scientific data to develop and commercialize innovative medical devices and nutritional products.
Industries
Nr. of Employees
small (1-50)
Alcresta Therapeutics, Inc.
Newton, Massachusetts, United States, North America
Products
Inline digestive enzyme cartridge for enteral feeding (commercial device)
Single-use inline cartridge that contains immobilized lipase on polymeric beads to hydrolyze fats in enteral formula prior to ingestion; intended to improve absorption of LCPUFAs and fat-soluble vitamins in tube-fed pediatric and adult patients.
Developmental next-generation cartridge for short bowel syndrome and bolus feeding
A development-stage iteration of the inline cartridge engineered for broader formula compatibility and bolus feeding use, evaluated in porcine SBS models for effects on enteral nutrition advancement and parenteral nutrition dependence.
Inline digestive enzyme cartridge for enteral feeding (commercial device)
Single-use inline cartridge that contains immobilized lipase on polymeric beads to hydrolyze fats in enteral formula prior to ingestion; intended to improve absorption of LCPUFAs and fat-soluble vitamins in tube-fed pediatric and adult patients.
Developmental next-generation cartridge for short bowel syndrome and bolus feeding
A development-stage iteration of the inline cartridge engineered for broader formula compatibility and bolus feeding use, evaluated in porcine SBS models for effects on enteral nutrition advancement and parenteral nutrition dependence.
Services
Clinical trial execution and registry services
Design and conduct of interventional and observational clinical studies and a pediatric direct-to-patient registry focused on enteral nutrition outcomes.
Preclinical study design and execution (large-animal models)
Conduct of porcine EPI and SBS models to evaluate fat absorption, intestinal adaptation, and safety of enteral enzyme cartridges.
Regulatory strategy and submission support for medical devices
Preparation of data packages and regulatory submissions leading to device clearances and label expansions with the FDA.
Payer engagement and market access support
Activities to secure reimbursement coverage including engagement with CMS and commercial payers, and achievement of billing code recognition.
Commercial manufacturing and supply chain services for single-use cartridges
Scale-up of production and distribution processes to support commercial launches of single-use enteral cartridges and management of supply-chain constraints.
Clinical trial execution and registry services
Design and conduct of interventional and observational clinical studies and a pediatric direct-to-patient registry focused on enteral nutrition outcomes.
Preclinical study design and execution (large-animal models)
Conduct of porcine EPI and SBS models to evaluate fat absorption, intestinal adaptation, and safety of enteral enzyme cartridges.
Regulatory strategy and submission support for medical devices
Preparation of data packages and regulatory submissions leading to device clearances and label expansions with the FDA.
Payer engagement and market access support
Activities to secure reimbursement coverage including engagement with CMS and commercial payers, and achievement of billing code recognition.
Commercial manufacturing and supply chain services for single-use cartridges
Scale-up of production and distribution processes to support commercial launches of single-use enteral cartridges and management of supply-chain constraints.
Expertise Areas
- Enteral nutrition device development
- Enzyme therapeutics applied to nutrition
- Preclinical large-animal modeling (porcine EPI and SBS)
- Clinical trial and registry management
Key Technologies
- Enzyme immobilization on polymeric bead carriers
- Inline enteral feeding cartridges
- Point-of-care enzymatic hydrolysis of enteral formula
- Preclinical porcine models for exocrine pancreatic insufficiency (EPI) and short bowel syndrome (SBS)