Blog

Actuated Medical Selected to Accelerate Neurological Technology Breakthroughs through NIH Blueprint MedTech Contract

[Bellefonte, PA] — Actuated Medical, Inc. is pleased to announce that it has been selected as a Contract Research Organization (CRO) under the National Institutes of Health (NIH) Blueprint MedTech (BPMT) initiative with a potential contract value of $35M over 5 years.

100 million people in the U.S. suffer from neurological diseases like Parkinson’s and Epilepsy. The problem is growing.  The U.S. expends $800 billion annually on the treatment of neurological conditions.  Recognizing the need for better diagnosis and treatments, the NIH has launched the BPMT program. The BMPT initiative assists innovators, facilitating moving their cutting-edge medical device developments toward Regulatory Approvals and commercialization, with support and resources that small companies and university researchers often lack.

Actuated Medical has been selected to offer extensive support to BPMT awardees that are working with the MedTech Hubs of CIMIT in Boston and NeuroTech Harbor in the Baltimore/DC area. This exciting partnership reinforces Actuated Medical’s commitment to advancing healthcare through groundbreaking research, development, and manufacturing. 

“We are thrilled to have been selected as a CRO for the BPMT initiative,” said Maureen L. Mulvihill, Actuated Medical President & CEO. “This program will allow us to support entrepreneurial researchers moving their groundbreaking devices toward first-in-man studies to transform treatment of neurological conditions like stroke, Epilepsy, and Parkinson’s Disease.“

The Actuated Medical BPMT contract provides comprehensive support to multiple BPMT grantees. This assistance encompasses the completion of biocompatibility studies, in vivo preclinical testing with adherence to good laboratory practice (GLP) guidelines, and sterilization and shelf-life testing crucial for advancing medical device development. Actuated Medical’s commitment extends to supporting research protocol development, facilitating in-house staff training, and conducting all necessary tests vital for biocompatibility, sterilization, and preclinical safety studies. These findings will serve as the cornerstone for informing regulatory filings, including Investigational Device Exemptions (IDEs), and eventual marketing approval by the US Food and Drug Administration (FDA).

This project has been funded in whole or in part with Federal funds from the National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N95023D00022.

About NIH Blueprint for Neuroscience Research:

https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint-medtech/resources

 

About Center for Innovative NeuroTech Advancement (CINTA):

https://www.cimit.org/web/center-for-innovative-neurotech-advancement

 

About and NeuroTech Harbor (NTH):

https://neurotechharbor.org/

Actuated Medical Expands Expertise in Forensic DNA Analysis with Acquisition of Mitotyping Technologies LLC

BELLEFONTE, PA, December 5, 2023 — Actuated Medical, a leading innovator in medical device technologies, announced today the successful acquisition of Mitotyping Technologies LLC, a prominent DNA forensic company specializing in advanced mitochondrial DNA analysis. This strategic move reflects Actuated Medical’s commitment to diversification and growth, expanding its capabilities into the field of forensic science.

Mitotyping Technologies LLC has established itself as a trailblazer in the DNA forensic industry, providing cutting-edge solutions for mitochondrial DNA analysis for over 24 years. The acquisition aligns with Actuated Medical’s vision to explore new avenues of innovation and leverage its expertise in precision engineering for applications beyond the medical field.

“We are excited to welcome Mitotyping Technologies into the Actuated Medical family,” said Maureen L. Mulvihill, CEO and Founder of Actuated Medical. “This strategic acquisition not only strengthens our portfolio but also positions us at the forefront of forensic mitochondrial DNA analysis. Mitotyping Technologies has a stellar reputation for delivering high-quality results, and we look forward to integrating their expertise into our broader mission of advancing science and technology.”

Mitotyping Technologies is known for its team of highly skilled scientists and exceptional success rate when working with minute, aged, and highly degraded samples. Using a unique, customized casework approach, Mitotyping Technologies has been instrumental in numerous forensic investigations.  This acquisition enables Actuated Medical to leverage Mitotyping Technologies’ extensive experience and established relationships within the forensic community.

“We are thrilled to join forces with Actuated Medical, a company known for its commitment to excellence and innovation,” said Gloria Dimick, Technical Leader and Forensic Examiner at Mitotyping Technologies. “Together, we believe we can push the boundaries of forensic mitochondrial DNA analysis, driving advancements that will have a positive impact on the field and contribute to the resolution of complex cases.”

The integration of Mitotyping Technologies into Actuated Medical’s portfolio enhances the company’s ability to address the growing demand for advanced forensic DNA solutions. The combined resources, knowledge, and technologies will empower Actuated Medical to make significant contributions to the field of forensic science.

 

About Mitotyping Technologies LLC:

Mitotyping Technologies, based in the vibrant State College area, shattered the myth surrounding the legendary Wild Bill Longley with an exuberant triumph. While Texas folklore hinted at his elusive escape from the hangman’s noose three times, Mitotyping Technologies definitively debunked the tale, proving his identity through forensic Mitochondrial DNA analysis. As a global leader in this field for over 20 years, their accredited DNA forensic laboratory has been instrumental in active criminal cases, post-conviction exonerations, cold cases, maternal relatedness, and missing persons investigations. Their unparalleled expertise extends to achieving superior recovery rates for mitochondrial DNA even in the most challenging samples. Mitotyping Technologies doesn’t just solve cases; they redefine what’s possible in forensic science with unmatched enthusiasm and dedication.

Actuated Medical Celebrates FDA 510(k) Clearance for their GripTract-GI™ Endoscopic Tissue Manipulator, Enhancing Complex Colonoscopy Visualization

Bellefonte, PA, November 15, 2023 – Actuated Medical, a leading innovator in medical device technologies, proudly announces the receipt of FDA 510(k) clearance for its groundbreaking GripTract-GI™ Endoscopic Tissue Manipulator (GripTract-GI). This milestone marks a significant advancement in minimally invasive procedures, empowering healthcare professionals with a state-of-the-art tool for enhanced precision and control in complex gastrointestinal interventions.

GripTract-GI, developed and patented by Actuated Medical’s team of experts, is designed to revolutionize endoscopic tissue manipulation, offering unparalleled maneuverability and versatility. With this FDA clearance, Actuated Medical reaffirms its commitment to delivering cutting-edge solutions that elevate patient care and procedural outcomes.

“The FDA clearance for GripTract-GI is a testament to Actuated Medical’s dedication to innovation and excellence in medical device development,” said Maureen L. Mulvihill, CEO and Founder of Actuated Medical. “This milestone underscores our commitment to advancing medical procedures, providing healthcare professionals with tools that redefine the possibilities of minimally invasive interventions.”

GripTract is a single-use device that connects to the distal end of an endoscope without occupying the working channel. It assists clinicians with optical visualization, diagnosis, and endoscopic treatment. It was developed under National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding.

Actuated Medical’s relentless pursuit of excellence is reflected not only in the GripTract-GI but also in the company’s overall portfolio, which spans various medical specialties. The FDA clearance reinforces Actuated Medical’s position as a leader in medical device innovation, poised to make a lasting impact on the landscape of minimally invasive procedures.

Revolutionary Tech Boosts Lifetime of Brain Implants for Neurological Conditions

BELLEFONTE, PA, August 17, 2023 – For over 16 million Americans grappling with neurological conditions like stroke, Parkinson’s, and paralysis, a groundbreaking solution is on the horizon to lost restore function. Brain computer implants hold the promise of restoring lost function. But they have a major challenge because the human body treats these implants as foreign bodies which triggers a response that limits the implant’s working lifetime. Actuated Medical’s innovative SonoShield™ Defender uses precisely engineered sound waves to help minimize this foreign body response. Early testing demonstrated the promise of the technology to extend implant working lifetime. To enable continued SonoShield Defender development, Actuated Medical, Inc. has been awarded a $2.2 million Fast-track Phase II Small Business Innovative Research (SBIR) project from the National Institutes of Health-National Institute of Mental Health (NIH-NIMH). Actuated plans to unveil the SonoShield Defender at the Neuroscience 2023 Conference, November 11-15, 2023 in Washington, DC.

 

“Our commitment to advancing medical technology is poised to make a lasting impact on the lives of millions. The SonoShield Defender has the potential to decrease the foreign body response that plagues many implanted medical devices. Commercialization of the technology will enable a future where neurological conditions are met with enhanced solutions that improve quality of life.” Maureen L. Mulvihill, Ph.D., Actuated Medical President, CEO, and Co-Founder expressed her excitement about the immense potential of this technology.

Advancing Healthcare Practices of Clogged Tube Management: The TubeClear System Launches an Online Training Course

BELLEFONTE, PA, August 3, 2023 – Actuated Medical is excited to announce the introduction of the TubeClear Online Training Course, now available at TubeClear.com. The TubeClear System, a patented medical device, helps Healthcare Practitioners maintain indwelling feeding tubes. These tubes play a crucial role in delivering life sustaining medication, nutrition, and hydration to patients who are unable to tolerate oral feedings due to conditions such as brain injury, Alzheimer’s, Parkinson’s, or stroke.

Recognizing the time constraints faced by healthcare professionals, Actuated Medical developed the TubeClear Online Training Course. The course equips Practitioners with the necessary knowledge and skills to effectively utilize the TubeClear system within a shorter timeframe. By doing so, Practitioners can maintain patients’ feeding tubes so that their life sustaining medication, nutrition, and hydration are delivered without disruptions, as prescribed.

“Actuated Medical’s team strives to improve patient outcomes with innovative medical devices. Our TubeClear system has been used by early Practitioner adopters for about 10 years, with no adverse events reported. This online training will expand the number of TubeClear proficient Practitioners beyond early adopters, leading to more effectively managed feeding tubes for a greater number of patients. This will result in improved outcomes for feeding tube patients,” expressed Maureen L. Mulvihill, PhD., Actuated Medical President, CEO, and Co-founder and TubeClear System Co-inventor.

Since 2013, the TubeClear System has consistently demonstrated its effectiveness in clearing sluggish and clogged feeding tubes, surpassing the performance of competing solutions in terms of speed and efficacy. The online training course covers aspects of the device and its functionality plus the setup procedures. The training allows Practitioners to train at a time convenient to them. Upon successful completion of the training course, Practitioners will receive a certificate recognizing their commitment to advancing their expertise in feeding tube management. The certificate can be given to the Practitioner’s institution as verification of training completion.

For more information on the TubeClear Training Course, please visit: https://www.tubeclear.com/courses/tubeclear-training/