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Clinician Innovation in Action

 

Angela LaRue
CEO, A LaRue Company

Participating in Day 1 Vignette: Insights from Clinician Innovators - Product Development Challenges and Lessons Learned

A LaRue Company was founded in 2019 by Angela LaRue, CEO and surgical nurse with years of multi-specialty surgical expertise (plastic surgery, general surgery, orthopedic, surgery, vascular surgery, and neurosurgery) and Chan LaRue, COO, who brings 30 years of experience in sales, marketing and business ownership.

A LaRue Company’s mission is to aid surgeons in providing a safe and effective way to remove breast implants and other gelatinous or similar surgical materials from the body. The company designed the LaRue Surgical Evacuator, a patent approved, FDA registered device, to aid surgeons in providing patients a safer, less invasive procedure, while also reducing procedure time and expense. The evacuator is also designed to addresses biohazard contamination by minimizing surgeon, surgical technician, nurse, and cleaning crew exposure to harmful biohazards.

The clinically tested LaRue Surgical Evacuator (LSE-01) is a hand-held, vacuum-powered body fluid suction apparatus that uses hospital/surgical center wall suction and has features including: 1) back flow valve and barbed hose connector, 2) nozzle ridges to indicate depth of insertion and provide sealing engagement, 3) a biohazard contamination cap, 4) nozzle neck 360-degree rotation feature, 5) control grip on the translucent device body that contains volume indicators and allows for viewing collected materials.

A LaRue Company will continue expand the Business and Scientific Advisory Teams and develop its corporate supporsters and partners. The company will partner with Health Wildcatters, LLC for its next round of funding and will attend the Health Wildcatters accelerator 2021 program in Dallas, Texas.

For more information:  
Angela LaRue, CEO: Angela@ALaRueCompany.com
Chan LaRue, COO: Chan@ALaRueCompany.com

Leon DeJournett, MD
CMO, Ideal Medical Technologies, Inc.
Pediatric ICU Attending Physician, Mission Hospital

Participating in Day 2 Session 3: Profiles in Health Care Innovation

 

Ideal Medical Technologies (IMT) goal is to fill a glaring need for an Artificial Pancreas system for use in the hospital setting, creating a new Standard of Care in glucose control for all ICU and diabetic patients. This technology (IMT FUSION system) will dramatically lower the cost of care and improve outcomes in all intensive care unit (ICU) patients as well as diabetic patients admitted to a non-ICU setting.

IMT has successfully completed proof of concept testing of its Artificial Intelligence based FUSION™ in animals, and is now cleared to begin human trials with the eventual goal of obtaining FDA approval. The FDA has granted Breakthrough Medical Device status to IMT’s FUSION system, which should help to expedite regulatory approval. Given the current COVID-19 pandemic and the potential of the FUSION artificial pancreas system to lower the COVID-19 mortality rate by up to 100%, IMT plans to apply to the FDA for an Emergency Use Authorization (EUA) with the goal of bringing the FUSION system to market by Q1 2023.

For more information: Steven Kane, CEO, Ideal Medical Technologies, Inc.
skane@idealmedtech.com or (215) 801-9937

Michael Schurr, MD
General Surgery Residency Program Director, MAHEC
Chair, Department of General Surgery, MAHEC
Founder/CMO, Imbed Biosciences

Participating in Day 2 Vignette: Celebrating Clinician Innovation - Stories of Inspiration

Imbed Biosciences is a privately held biotech company registered with FDA as a medical device manufacturer with an ISO 13485 certified quality management system. The company has a portfolio of products in development based on its patented Microlyte® technology to combat local pain and infections in complex wounds such as burns, chronic ulcers, surgical wounds, epidermolysis bullosa, and colorectal surgeries. A portion of Imbed’s research funding comes from the National Institute of Arthritis, Musculoskeletal, and Skin Diseases (NIAMS).

Microlyte® Matrix provides the combination of a synthetic wound matrix and moisture management to facilitate healing in acute and chronic wounds. The nanofilm matrix is coated with a 20-micron layer of resorbable polyvinyl alcohol (PVA) to provide moisture management and product handleability. The nanofilm matrix contains a low level of ionic and metallic silver (<25µg/sq cm) to prevent microbial contamination and colonization of the matrix.  Reduction of bacterial bioburden may reduce microbial colonization and risks of wound infection. Microlyte® Matrix facilitates healing in acute and chronic wounds through the matrix function of the PEM nanofilm. The PEM component of Microlyte® Matrix contains both anionic and cationic charged polymeric components which serve to shield approaching granulation cells from the generally disorganized surface chemistry common to wound beds. This masking provides a functional molecular matrix or template to facilitate the granulation process in the healing wound. The ultrathin formfactor of Microlyte® Matrix allows it to rapidly absorb wound fluid and transform into a material that intimately contours to the underlying wound bed. This places the matrix directly on the wound bed where it is most beneficial to the healing process. The hydrophilic and resorbable PVA in Microlyte® Matrix maintains a physiologically moist microenvironment in the wound, which further facilitates wound healing.

In a recent study, thirty-two patients with a total of 35 chronic, nonhealing wounds of varying types were treated with Microlyte® Matrix once every three days.  At 3 weeks, 72% of wounds had significantly improved healing with an average wound area reduction of 66%. By 12 weeks, 91% of wounds either healed completely or improved significantly with an average wound area reduction of 73%.  The application of Microlyte® Matrix was safe and well tolerated, and it facilitated improvements in healing of a majority of the complex chronic wounds studied.  The full article is published in WOUNDS. “Efficacy of a Bioresorbable Matrix in Healing Complex Chronic Wounds: An Open-Label Prospective Pilot Study. Wounds 2020;32(11):309–318”.

For more information: https://www.imbedbio.com/contact/

Iltifat Husain, MD
Co-founder, Impathiq, Inc.
Assistant Professor of Emergency Medicine, Wake Forest University School of Medicine

Participating in Day 2 Session 3: Profiles in Health Care Innovation

Impathiq™ is a clinical decision support company founded in 2016 by emergency medicine physicians dedicated to solving the complex and costly challenge of chest pain evaluations in the emergency department. With the introduction of HEART Pathway™ in 2017, Impathiq became the industry leader in validated decision support designed to risk-stratify patients for early discharge, benefitting both the patient and health system with enhanced safety, lower costs, and improved quality of care.

Today’s Solutions are Inefficient. Most health systems rely on static, non-integrated protocols for chest pain, making it challenging to monitor usage, maintain uniformity of care, and ensure compliance. By contrast Impathiq's decision support platform enables health systems to create advanced, fully integrated care pathways that offer clarity and transparency to providers and administrators. Impathiq Clinical Decision Support (CDS) offers a sophisticated and easy-to-use clinical decision support platform for the management and care of chest pain patients in the ED. Embedded within your hospital’s EMR, Impathiq CDS puts your cardiac protocol at the fingertips of your physicians at the exact time of need. Saving Hospitals and Clinicians valuable time and money.

For more information, email to contact@impathiq.com

David Gomez, CRNA
CEO/CTO, Infinitus Medical Technologies 

Participating in Day 1 Vignette: Insights from Clinician Innovators - Product Development Challenges and Lessons Learned

Infinitus Medical Technologies is a clinically founded surgical innovations company focused on evolving surgical positioning, surgical infrastructure, and modular powered technologies that bring balance to patient and staff safety. Each of our systems are created from a clinical perspective to overcome traditional failures in designs, processes, and utility. Our solutions were specifically designed to facilitate highly reliable processes and behaviors needed to evolve performance, while reducing  variance and safety risks common to the industry.  iMT® is a Veteran owned and US manufactured company. 

For more information: sales@infinitusmedical.com or 919-285-1178 

Andrew Prince, MD
CEO, Lira, Inc.
Resident Surgeon, UNC Department of Otolaryngology - Head & Neck Surgery

Participating in Day 2 Vignette: Celebrating Clinician Innovation - Stories of Inspiration     

LiRA is developing AI-based video-to-speech technology, delivered first through a non-invasive, immediate, voice restoration software that effectively provides autonomous lip-reading. The technology aims to empower the >1M Americans suddenly rendered voiceless each year from procedures like tracheostomy and laryngectomy.

LiRA’s software is designed hardware agnostic. Using a smart device, video feed input data is captured of the voiceless individual attempting speech. The company’s proprietary algorithm translates visual phonemes (visemes) into words that are played aloud and presented as text on the screen. To ensure an equitable technology, a large volume of diverse video training examples is required.

Through LiRA’s micro-volunteerism LipTrain campaign (www.liraglobal.com/liptrain) anyone, anywhere can help contribute to the company’s mission! LiRA’s dream is to help alleviate the 3-fold increase in adverse effects (vs matched, speaking patients) and mitigate the ~$9B lost across the US healthcare system annually due to poor communication secondary to this aphonic handicap.

 You can check LiRA out at www.liraglobal.com or contact the company at info@liraglobal.com.

Chuck Scarantino, MD
Co-founder, Lucerno Dynamics, Inc
Locum Tenens Radiation Oncologist

Participating in Day 1 Vignette: Insights from Clinician Innovators - Product Development

Lucerno Dynamics is a medical technology company that provides solutions for nuclear medicine customers. The Lara® System, developed by Lucerno Dynamics, provides quality control, necessary information for accurate dosimetry, and quality assurance for radiopharmaceutical administrations to ensure that radiation is administered as intended. An ideal administration of diagnostic and therapeutic radiopharmaceuticals is critical for patient care and safety. Recently, Lucerno partnered with Siemens Healthineers to distribute the Lara® System as part of their portfolio of medical imaging products. 

For more information: Iryna Barvi ibarvi@lucerno.com 

Patrick Codd, MD
Neurosurgeon, Duke University Hospital 
Co-founder/CMO, Mente. Inc. 

Participating in Day 2 Vignette: Celebrating Clinician Innovation - Stories of Inspiration

Which surgical instruments do you actually need? The automated Mente surgical instrument tracking process allows each surgical instrument to be recorded as it enters the surgical field.  This ensures immediate and accurate identification of exactly when, and for how long, that instrument is used. Applied across the entire suite of surgical instruments, our unique data stream provides detailed statistics on instrument usage by procedure, operating room, time, surgeon, and surgical instrument trays.  In our pilot studies, instrument supply was reduced by 50%.  This means substantial cost savings for the hospital, faster operating room setup times, and reduced instrument tray weights. In subsequent operations, none of the eliminated instruments were requested by the surgeon. The data is gathered automatically, minimizing the impact on the busy clinical operation.  

Mente powers its products by tracking surgical instruments in the operating room, creating dependable, real-time data streams that transform OR resource management.  The company’s mission is to use predictive analytics to create the best surgical experience at the lowest cost for the hospital, the surgical team, and the patient.  The automated Mente tracking process does not rely on employing manual observers or surgical committees to provide anecdotal information on instrument usage for optimization programs. The system and data collection service operates continuously as surgeries take place. The resulting information and optimization techniques stay in-house, unlike the fleeting nature of consultant engagements.  With this solution, Mente envisions a surgery where the care team has exactly what they need, when they need it.  

For more information: weshill@mentemedical.com 

Karen Tsang, RN, BSN, CPN
Founder/President, MyKare, Inc.
Pediatric Clinical Nurse, WakeMed Health and Hospital

Participating in Day 2 Session 3: Profiles in Health Care Innovation

MyKare, Inc. designs and develops innovative solutions to help parents better care for common pediatric illnesses and prevent unnecessary physician and emergency room visits.

Every child will likely have a nasal infection by the time they are two years old. Each year, 800,000 kids visit the emergency room with a stuffy nose. If left untreated,  it can become severe and require a hospital stay. The company’s first product is a nasal suction device, KynoKit, which addresses the need for a safer, effective nasal suction device to clear a baby’s stuffy nose.  Nasal suctioning devices are available, however, most are ineffective and some can cause damage to the baby’s nose.

MyKare has developed KynoKit, a suction device based on the gold standard hospital suction system concept. MyKare’s 2-in-1 design allows irrigation of saline through one nasal port and aspiration of secretions of nasal cavity using another port with a simple one-handed motion by one user. KynoKit will be the only effective mechanical product on the market that can irrigate, aspirate, and dispose of nasal mucus to alleviate stuffy nose. 

For more information, contact Karen Tsang at karentsang51@gmail.com 

T. Bruce Ferguson, MD
CMO/Co-founder, Perfusio Corp.
Chief Visiting Research Scientist, Depts of Engineering, Physics and Surgery, East Carolina University

Participating in Day 1 Session 3: Market Translation & Commercialization     

Perfusio Corp. is a medical device company in Greenville, North Carolina, that has developed an FDA-cleared, Class II technology platform for surgical imaging that provides surgeons instantaneous data and visual images of blood flow distribution (flow and perfusion) in tissues, up to a depth of 4-5mm, during surgery to augment medical decisions. Perfusio’s Certes™ utilizes the combination of near-infrared and visible light with laser speckle imaging to produce “multi-spectral physiologic visualization, “MSPV” platform technology. It does not require patient contact, dyes, or ionizing radiation, so it is safe for patients and clinicians. The company’s interoperative technology is driven by artificial intelligence and advanced analytics to improves surgical efficiency and patient outcomes, avoids preventable surgical errors and complications, and creates significant healthcare savings while also saving lives.

Up to 15% of key surgical procedures have major complications, including death, that many times results from poor visualization of blood flow and tissue perfusion during the surgery. Visible light can only show the surface anatomy, so surgeons must make clinical decisions with incomplete information.

Certes™ from Perfusio resolves this dilemma by providing real-time visualization of blood flow and tissue perfusion during surgery. This additional knowledge enables surgeons to make better-informed and more accurate decisions at critical junctures. The new knowledge generated by Certes™ remains accessible after the procedure in the Perfusio-ARMUS Cloud Repository via a secure surgical web portal. This aggregate procedural and associated patient outcome data form the basis for future real-time individual patient predictive analytics.

For more information, contact B. Tucker, monte.tucker@perfusio.com or 252-656-0404 ext. 1006 (offfice)

Candice Curtin, RN, BSN, WCC, DWC, OMS
CEO/Founder, Pressure Dx, LLC
Director, New Hanover Regional Medical Center Wound Care Clinic

Participating in Day 1 Session 2: Development: How to make it happen!

Pressure injuries (also known as bedsores or pressure ulcers) kill more than 6 Americans every hour. There are over 17,000 lawsuits related to pressure injuries annually which settle in favor of the patient 87% of the time. Pressure injuries are classified using a national staging system which determines the severity of the wound, the diagnosis code, the equipment a patient is eligible for, the reimbursement, and can also help determine the treatment.  Therefore, the stage is of the utmost importance. Despite this, healthcare providers stage pressure injuries incorrectly more than 50% of the time.   

Our woman owned company, based in Wilmington, NC, found a solution to this issue by developing Pressure Dx. Pressure Dx is a patented, clinical decision support software for pressure injuries that provides the correct stage, ICD-10 diagnosis code, treatment recommendations, and the necessary documentation to support the stage. It provides this information with 100% accuracy in less than 1 minute on average. Proven in several clinical trials, it is a necessity for all healthcare organizations caring for pressure injury patients. Pressure Dx can help decrease litigation risks, reduce costs, and improve overall outcomes. Visit us at www.pressuredx.com for more information.  

For more information: Candice Curtin, CEO/Founder, candice@pressuredx.com or  910-619-9393