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.
130 Turner Street, Building 3, Suite 200, Waltham, MA 02453 USA
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
Design and conduct of interventional and observational clinical studies and a pediatric direct-to-patient registry focused on enteral nutrition outcomes.
Conduct of porcine EPI and SBS models to evaluate fat absorption, intestinal adaptation, and safety of enteral enzyme cartridges.
Preparation of data packages and regulatory submissions leading to device clearances and label expansions with the FDA.
Activities to secure reimbursement coverage including engagement with CMS and commercial payers, and achievement of billing code recognition.
Scale-up of production and distribution processes to support commercial launches of single-use enteral cartridges and management of supply-chain constraints.
Design and conduct of interventional and observational clinical studies and a pediatric direct-to-patient registry focused on enteral nutrition outcomes.
Conduct of porcine EPI and SBS models to evaluate fat absorption, intestinal adaptation, and safety of enteral enzyme cartridges.
Preparation of data packages and regulatory submissions leading to device clearances and label expansions with the FDA.
Activities to secure reimbursement coverage including engagement with CMS and commercial payers, and achievement of billing code recognition.
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)
News & Updates
Alcresta Launches Innovative Enzyme-Based Nutritional Company
Announcement of a $10 million Series A venture capital financing to support the development of enzyme-based nutritional products for various patient populations.
Alcresta Announces Commercial Availability of Next-Generation RELiZORB Cartridge
Introduction of a new FDA-cleared enzyme cartridge expanding the utility and compatibility of RELiZORB for broader patient use.
Alcresta Announces FDA Expanded Use Clearance for RELiZORB in Pediatric Patients 2-5 Years Old
FDA clearance allowing use of RELiZORB in children as young as 2 years old, broadening access for pediatric patients with fat malabsorption.
Alcresta Announces FDA Expanded Use Clearance for RELiZORB in Pediatric Patients 1 Year and Older
FDA clearance for use in children down to age 1, further expanding the patient population benefiting from RELiZORB.
Alcresta Announces Series of Commercial Milestone Achievements for RELiZORB
Company reports profitability, increased sales, and expanded payer coverage for RELiZORB.
Alcresta Announces Move to New Corporate Headquarters in Waltham, MA
Relocation of company headquarters to enhance collaboration and support growth.
Alcresta Launches Innovative Enzyme-Based Nutritional Company
Announcement of a $10 million Series A venture capital financing to support the development of enzyme-based nutritional products for various patient populations.
Alcresta Announces Commercial Availability of Next-Generation RELiZORB Cartridge
Introduction of a new FDA-cleared enzyme cartridge expanding the utility and compatibility of RELiZORB for broader patient use.
Alcresta Announces FDA Expanded Use Clearance for RELiZORB in Pediatric Patients 2-5 Years Old
FDA clearance allowing use of RELiZORB in children as young as 2 years old, broadening access for pediatric patients with fat malabsorption.
Alcresta Announces FDA Expanded Use Clearance for RELiZORB in Pediatric Patients 1 Year and Older
FDA clearance for use in children down to age 1, further expanding the patient population benefiting from RELiZORB.
Alcresta Announces Series of Commercial Milestone Achievements for RELiZORB
Company reports profitability, increased sales, and expanded payer coverage for RELiZORB.
Alcresta Announces Move to New Corporate Headquarters in Waltham, MA
Relocation of company headquarters to enhance collaboration and support growth.