Pediatric Device Stakeholders

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Annoviant Awarded SBIR Phase II Grant from the NIH

Annoviant Awarded $1.85M SBIR Phase II Grant from the National Institutes of Health

Funding will help drive commercialization of next-generation pulmonary valve conduit for pediatric patients

ATLANTA--()--Annoviant LLC, formerly TGen Tech LLC, today announced that it has been awarded a grant of $1.85 million for two years by the National Institutes of Health (NIH) to help further its development and commercialization of the TxGuard™ pulmonary-valved conduit. This is a continuation of the Phase I Small Business Technology Transfer (STTR) grant the company received in 2019.

“We’re extremely pleased to receive this grant, and we are grateful for the National Heart, Lung, and Blood Institute’s financial support”

The new conduit represents breakthrough technology in conduit replacements for the treatment of congenital heart disease (CHD). Tailored largely toward pediatric patients, the device is designed to resist early degeneration and allows regeneration with host cells, enabling the device to grow with children.

CHD affects approximately 40,000 newborns each year in the U.S. Valve and conduit replacements are needed for absent pulmonary valve, aortic stenosis (Konno procedure, Ross, procedure), double outlet right ventricle (Rastelli operation), extracardiac conduit (Fontan operation), and pulmonary valve replacement (Tetralogy of Fallot).

“We’re extremely pleased to receive this grant, and we are grateful for the National Heart, Lung, and Blood Institute’s financial support,” said Ajay Houde, Ph.D., MBA, co-founder and CEO, Annoviant. “The grant funding will enable us to address the clinical and cost challenges associated with treating CHD in children.”

The primary issues currently observed with commercial devices are (a) calcification; (b) thrombosis; and (c) infection. Annually, 40,000 (U.S.) and 1.3 million (global) children are born with CHD, resulting in 4%-6% of neonatal deaths. According to the Centers for Disease Control and Prevention (CDC), there are about 2.9 million CHD patients in the U.S.

Pediatric patients with CHD typically undergo 3 to 5 cardiovascular surgeries over their lifetimes with an estimated total cost of $5.61 billion1 to the U.S. healthcare industry for treatment of CHD patients.

The TxGuard “scaffolding” exhibits clinical advantages over commercial products, specifically its cutting-edge qualities that make it resistant to calcification (plaques), thrombosis, and infection. Its ability to regenerate and grow with patients also is a significant distinguishing benefit.

About Annoviant

Annoviant LLC, formerly TGen Tech LLC, is a medical device company founded in 2018 and currently collaborating with a broad ecosystem, including research institutions and industry partners across the country. Fueled by personal experiences of its co-founders, the company is driven by a passion to make a positive difference in the lives and treatment of congenital heart disease (CHD) patients. The new TxGuard™ portfolio of devices can address the clinical challenges and significantly reduce healthcare costs by eliminating the required repeat surgeries. The company is developing cardiovascular devices for structural heart treatments.

NIH: Research reported in this news release was supported by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) under Award Number R44HL147771. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

1 https://www.cdc.gov/ncbddd/heartdefects/features/keyfindings-hospital-costs-resource-use.html

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Originally published on BusinessWire.

 

PMD Launchpad

The PPDC is excited to announce a new website for stakeholders of pediatric devices! The website is called the PMD Launchpad (https://pmdlaunchpad.org/) and will be a common platform for stakeholders to go for both entry-level and advanced information on pediatric medical device development.

The vision is for stakeholders to visit one location for necessary information at any level of device innovation. The website includes helpful Knowledge Centers and Resources for device development, as well as spotlights for pediatric devices and device pioneers, a blog with current topics, and other news and events.

We hope this site will serve an audience beyond just the PPDC where visitors can learn and be directed to other resources for further information. Please visit the site and share with others interested in pediatric device development.

And please follow the PMD Launchpad on LinkedIn and Twitter to be notified of new content!

Five Proposals Receive Seed Funds to Develop Medical Devices for Children

Published on in CHOP News.

The Pennsylvania Pediatric Medical Device Consortium (PPDC) has announced its latest round of seed grants to companies developing medical devices for children. The Consortium chose five projects from nine finalists in a competition to receive seed grants of $50,000 each.

The devices are a telehealth tool to track newborn development, a wearable phototherapy device, a portable oral aspirator, a novel endotracheal tube, and a one-step adrenal crisis management device.

Funded by the U.S. Food and Drug Administration and based at Children’s Hospital of Philadelphia (CHOP), the PPDC provides know-how and seed funding to help innovators translate promising ideas into commercialized medical devices for use in children. The PPDC is a collaboration involving CHOP, the McGowan Institute for Regenerative Medicine and sciVelo of the University of Pittsburgh, and the University of Pennsylvania.

The new round of awards is the eighth by the PPDC, following seed grants announced in February 2015January 2016January 2017October 2017July 2018May 2019, and February 2020.

“This round’s sponsored device projects represent a range of clinical disciplines and will provide novel solutions to unmet needs in pediatric healthcare,” said Robert J. Levy, MD, attending cardiologist in the Cardiac Center at CHOP, the William J. Rashkind Endowed Chair in Pediatric Cardiology at CHOP and the Consortium’s Principal Investigator. 

Neoneur LLC of Pennington, NJ is creating the Neoneur, a telehealth-enabled device that provides objective measurements of infant oral feeding capability and developmental status. An infant’s feeding skills consist of patterns driven by the brain to enable adequate nutrient consumption and respiratory protection at the same time without hindering growth. All infants must have feeding skills to thrive, but currently clinical observation is the only means to assess them. The Neoneur will enable the ability to monitor feeding and skill development for at-risk infants both in the hospital and through telemedicine at home to enable earlier discharge, decrease readmissions, and aid in early identification of developmental issues.

TheraB Medicala pediatric startup out of Michigan, is developing SnugLit, a wearable infant swaddle that treats neonatal jaundice with phototherapy. Neonatal jaundice affects 2.4 million infants in the United States and as many as 20 million globally. The most common treatment involves light therapy systems, which require constant monitoring by nursing staff and cause prolonged separation of mother and child. With SnugLit, babies no longer have to be separated from their parents during phototherapy, but instead can receive complete treatment in the arms of their caregivers.

Tychermont Products LLC of Philadelphia will receive support for the OrVac™, a portable oral aspirator to assist patients with pediatric dysphagia and other swallowing disorders. To date, these patients do not have a way to self-suction oral waste without assistance. The OrVac™ returns control and independence to the patient by providing a portable, non-invasive, and user-controlled device to evacuate oral liquids.

 

Tychermont OrVac device

The University of Illinois at Chicago, in partnership with Olifant Medical Inc, will receive support for Dr. Girish Deshpande’s work on the SecureTube™, a new endotracheal tube with several features designed to mitigate various factors that lead to unplanned extubations in pediatric patients. Unplanned extubations can lead to significant complications, especially in young infants, who could suffer cardiac arrest requiring CPR and may need an emergency re-intubation. Unplanned extubations are also associated with increased respiratory tract infections, increased length of ICU and hospital stays, and an overall increase in healthcare cost. The unique two-port design of the SecureTube™ and its specially designed holder will standardize the way endotracheal tubes are secured to the patient. It will replace the currently used Y-adapter and bite-block and will eliminate the use of tape that will minimize, if not eliminate, the unplanned extubations and associated complications.

SOLUtion Medical LLC of Philadelphia is developing the TwistJect™, a device that enables caregivers to manage children during an adrenal crisis. Adrenal crisis is a life-threatening condition resulting from insufficient levels of the hormone cortisol. Children and adolescents experience some of the most severe morbidities of all patients who experience adrenal crisis due to the difficulties in managing adrenal insufficiency in younger populations and the difficulties in providing rescue injections. The TwistJect™ is a one-step delivery device that reconstitutes hydrocortisone sodium succinate and removes all entrapped air in one user step.

Applications for PPDC funding opportunities are accepted from throughout the U.S. The Consortium also accepts applications year-round for in-kind services and expert advice.

Little Sparrows Technologies Receives FDA Clearance for an Innovative, Portable Medical Device for Treating Infant Jaundice

Start-up receives FDA 510(k) clearance for bili-hut™ Neonatal Phototherapy System, a cost-effective phototherapy device for treating infant jaundice at home or in a hospital.

From www.little-sparrows-tech.com:

Somerville, MA, September 17, 2019 – Little Sparrows Technologies, a neonatal medical device startup committed to promoting the well-being of newborns, announced today it has received 510(k) clearance from the Food and Drug Administration (FDA) for the bili-hut™. The bili-hut is an innovative ultraportable neonatal phototherapy system that leverages a bassinet-like design to treat hyperbilirubinemia, commonly known as neonatal jaundice. The device features a unique curved light emitting diode (LED) illumination canopy that delivers high-intensity blue light phototherapy. This highly portable device allows newborns to effectively undergo jaundice treatment anywhere – at home or in a hospital setting.

“Neonatal jaundice is very common and is often diagnosed when a newborn is almost ready for discharge from the hospital or after the baby is home for a few days, requiring longer hospital stays or readmittance,” said Dr. Donna Brezinski, CEO and founder, Little Sparrow Technologies. “Phototherapy treatment typically occurs in NICUs, which separates newborns from their mothers who are bonding and establishing breast feeding. The bili-hut provides the best possible start for jaundiced babies by enabling treatment at the mother’s side, whether in the hospital or at home.”

Neonatal jaundice is a transitional phenomenon which affects three out of five newborns in their first weeks of life. Jaundice causes a yellow discoloration of the skin and eyes in newborns and typically subsides within a few days. In newborns with severe jaundice, blue light phototherapy is required to prevent irreversible neurologic injury.

Jaundice is also one of the most common diagnoses associated with infant readmission to a hospital in the first month of life. In the United States, it is estimated that 100,000 infants develop severe jaundice, costing the healthcare systems $500M annually for hospital-based care. Hospital phototherapy devices can be daunting for new parents and extended hospital stays are often stressful and expensive.
Invented by Dr. Brezinski, a neonatal-perinatal specialist, the bili-hut is capable of delivering hospital intensity phototherapy at the parent’s bedside in either the postpartum room or at home, presenting a new, innovative and cost-effective approach to addressing the challenges of treating jaundice. With the bili-hut doctors can improve the quality of care for infants by maintaining a close relationship with parents while helping to reduce emergency room visits and readmissions.

The bili-hut will be on display at the Little Sparrows Technologies booth #133 at the 2019 American Academy of Pediatrics National Conference & Exhibition in New Orleans, October 26-28.
For more information on the bili-hut, visit www.little-sparrows-tech.com.

About Little Sparrows Technologies:

Founded in 2013 by Harvard Medical School affiliated doctors, Little Sparrows Technologies offers an innovative approach for treating jaundice. The bili-hut™ is a cost-effective phototherapy device that uses blue LED lights in a reflective bassinet that is capable of operation on battery power. It is simple to use and collapsible for easy transport. Little Sparrows has received two phases of funding from the NIH’s Small Business Innovation Research (SBIR) program, and The World Health Organization included the bili-hut in its Compendium of Medical Devices for Global Health. Little Sparrows Technologies was the winner of a 2018 Patents for Humanity Award. The company offers solutions to support hospitals, US pediatrician offices and international implementations. For more information, visit www.little-sparrows-tech.com.
 


Links

Provides an overview of the FDA's PDC program, of which we are part

 

Provides guidance regarding device classification, basic regulatory requirements for approval, Quality System regulation, labeling requirements, and medical device reporting

 

 

Allows you to search the database of issued U.S. patents

 

       An institute based at the University of Pittsburgh with a primary focus of the development of technology to address tissue and organ insufficiency.

 

       A medical device development firm with a commercialization process focused on building value, risk reduction, design for manufacture, and shortening time to market.

 

A partner organization of the PPDC. NAMSA is a medical research organization providing expert regulatory, laboratory, clinical, and compliance services to medical device and healthcare product manufacturers. 

 

Provides information about the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, including opportunities to apply for federal funding to support small companies in research and development that has a strong potential for commercialization

 

Penn Health-Tech unites the University of Pennsylvania’s strengths in Medicine, Engineering, Business and Education to create technologies that address the world’s pressing health care needs.

 

sciVelo is part of the University of Pittsburgh Innovation Institute accelerating life and health sciences translational research and commercialization.

 

  • To access the other Pediatric Device Consortia:

National Capital Consortium for Pediatric Device Innovation

Southwest National Pediatric Device Consortium

UCSF-Stanford Pediatric Device Consortium

Consortium for Technology and Innovation in Pediatrics