Investment Portfolio
We engineer motion to solve major, unmet clinical needs in gastroenterology & neurology.
Management Team
- Maureen Mulvihill, PhD | CEO
- Roger Bagwell | Dir. R&D
- Chris Lahr | Dir. Bus & Finance
- Douglas Dillon | Dir. QA & RA
- Ian Charney | Dir. Manufacturing
- Fredrick Browne, MD | CMO
- Medical Advisory Board (9 members)
- Board of Directors (7 members)
Company Milestones
- GripTract FDA cleared, patented, pending clinical studies.
- TubeClear FDA cleared, patented, early adopters, clinical use, repeat sales.
- Neural Implant Technologies early adopter interest, preclinical sales.
Industry
Medical Device, Product Innovator
Fund Raising Objectives
Seed Round
Intellectual Property
US Patents
International
Registered Trademarks
Strategic Focus – 3 Core Solutions
GripTract-GI™ Manipulator
TubeClear® System
Neural Implant Technologies
ESD is a minimally invasive procedure to remove large (>20mm) polyps in the GI tract. It offers significant advantages over traditional methods, including organ preservation, a lower recurrence rate, and enhanced visibility during procedures. However, the complexity of ESD often poses challenges due to the learning difficulty and long procedure time. That’s where our innovative device, GripTract, comes in—designed to reduce the ESD learning curve and shorten procedure times thus may increase ESD adoption.
FDA Cleared, patented, and pending clinical studies for endoscopic tissue manipulation.
IP claims: We hold 2 U.S. and 2 international patents directed to an endoscopic accessory that includes selectively movable engagement members that enhance procedural efficiency through tissue manipulation and interaction with standard endoscopic tools. Additional U.S. and international pending patents directed to an integrated endoscopic tool that provides selectively movable engagement members and working channels for conventional endoscopic instruments*
Competitive Advantage: GripTract 1) provides continuous, adjustable traction during advanced endoscopic procedures, 2) leaves the working channel open for other tools, and 3) is simple to use.
Total Available Market: Endoscopy equipment market is valued at $32B. Assuming accessories are 10% of the market, accessories have an estimated $3B market.
First Market: Endoscopic submucosal dissection (ESD) is a growing market. The ESD Total Available Market is projected to be $154M by 2032.
Additional Market Opportunities: GI system foreign body removal; Gastric tumor resections; GIST – gastrointestinal stromal tumor; Conditions at the esophagogastric junction (EGJ) – typically hard to get to; Submucosal tunnel endoscopic resection (STER) – tunnel to region then take out a section of tissue; anti reflux mucosectomy.
Commercialization Plan: In discussions with large endoscopy companies, they expressed strategic interest and exit potential once we build the training and sale procedures, engage KOLs, build 6/7 key accounts.
*For more information on Actuated Medical patent and IP portfolio click here
*The TubeClear System is a two-part system where the Clearing Stem (disposable) is inserted into the tube. The Control Box motor (reusable) magnetically attaches to the Clearing Stem and moves the Clearing Stem wire backward/forward clearing sluggish and clogged feeding and decompression tubes in adults. It has been used over 4000 times in last 10 years with no reported Adverse Events to the FDA MAUDE database. Indications have been expanded under 6 FDA 510(k) clearances to include most adult feeding and decompression tubes. Pending pediatric studies will enable the pediatric indication.
FDA Cleared, patented, clinical use, and repeat sales for feeding and decompression tubes.
IP claims: We hold 13 U.S. and 11 international patents that focus on devices and methods for effectively clearing artificial tubes, primarily aimed at in-situ clearing within living organisms.*
Competitive Advantage: TubeClear 1) clears sluggish feeding and decompression tubes faster and more effectively, 2) works in indwelling tubes, and 3) at bedside by certified and/or licensed healthcare practitioners.
Market Size: Medical tube market is valued at $11B. Urinary (Foley) catheter market is valued at $2.6B with 100M urinary catheters are sold worldwide. A potential second market for the TubeClear System is clearing Foley catheters. TubeClear-Foley would have an estimated total available market of $2.6B.
First Market: Feeding tube market $4.2B. Assuming a 25% clog rate, TubeClear for clearing feeding tubes has an estimated total available market of $1B.
Additional Market Opportunities: Medical tube clearing such as Foley catheter clearing.
Commercialization Plan: In discussions with large enteral therapy companies, they expressed strategic interest and exit potential once we obtain more clinical evidence (IRB studies) and build awareness in nursing schools. In addition, complete V&V testing and FDA 510(k) submission for a Foley catheter clearing system.
*For more information on Actuated Medical patent and IP portfolio click here
16M Americans are candidates for brain implants to treat their neurologic conditions. However, the force required to insert these tiny implants raises several challenges including 1) buckling or breaking the electrode, 2) causing brain tissue dimpling and electrode deflection, limiting precision placement, and 3) causing tissue damage which provokes the immune system to react, walling off the electrode and reducing the electrode’s working life. Actuated is revolutionizing how neural devices are inserted.
Discussions ongoing with potential clinical partners and preclinical tool sales.
IP claims: SonoShield: We have 2 U.S. and international patents pending that cover a device that employs focused low-intensity pulsed ultrasound to improve the longevity and performance of neural electrodes by reducing the body’s response to tissue trauma at the implant site. NeuralGlider: We hold 6 U.S. patents and have multiple U.S. and international patents pending focused on devices and methods to reduce insertion force and minimize tissue damage during implant insertion utilizing ultrasonic micro-vibrational technology.*
Competitive Advantage: Our expertise in electronically designing and driving ultrasonic (high frequency sound waves) technologies is enabling less trauma, greater precision and longer working lifetimes in brain implants in research models. Researchers are publishing their data (to date 20 articles on NeuralGlider and 1 article on SonoShield) showing improved safety and efficacy with our technologies. The lessons learned and data will be used as we develop clinical systems.
Market Size: The Brain computer interface and brain monitoring market size is valued at $10.4B.
First Market: Preclinical market size is estimated at $22M. This is advantageous for real world safety and efficacy data for future FDA submissions.
First Human Market: 16M Americans are candidates for BCIs to treat their neurologic conditions. Of those 300k suffer from spinal cord injuries. For spinal cord BCI systems integrated with Actuated technology, Actuated’s projected potential revenue is $1B.
Commercialization Plan: Preclinical sales and research data will be used to inform future FDA submissions. Currently seeking strategic partnerships to integrate our IP into their system. With superior clinical data, the strategic partner will license the technology for their clinical indication. Multiple licensing opportunities will be possible for different clinical indications.
*For more information on Actuated Medical patent and IP portfolio click here