TX Fannin Innovation Studio announces its receipt of a $2,000,000 Phase II Small Business Innovation Research grant from the National Institute of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development for development of its ChorioAnchor device, in partnership with Texas Children’s Hospital, Baylor College of Medicine , and Texas A&M University .
The ChorioAnchor device is designed to assist maternal-fetal surgeons in reducing the risk of preterm birth and infections commonly associated with fetal surgery. Each year, more than 120,000 babies are born with a fetal defect, of which 50,000 could potentially be repaired prenatally. These defects affect quality of life and require hospital stays that cost the healthcare system an estimated $23 billion per year. The landmark MOMS trial in 2011 demonstrated the benefit of fetal surgery for spina bifida patients and its potential application to patients with other conditions.
The ChorioAnchor program is part of the Innovation Partnership for Pediatric Products (IP3), a unique three-way partnership between Texas Children’s/BCM, TAMU, and Fannin, for the development of novel pediatric devices. Maternal-fetal surgeons at Texas Children’s/BCM, Drs. Jimmy Espinoza and Michael Belfort recognized the unmet need and conceived of the approach. A senior design team and graduate students at TAMU developed and iterated on early prototypes under the direction of Dr. Balakrishna Haridas. Fannin led the program development and funding, including a successful Phase I SBIR grant in 2017, followed by the recent Phase II award.
Although the discipline of fetal surgery is relatively new, significant collaborative efforts and resources have been invested in identifying fetal conditions that could potentially benefit from fetal interventions. However, these efforts are hindered by the risks associated with these interventions, including preterm premature rupture of membranes (PPROM) and premature delivery. The most frequent complication of any fetal surgery is PPROM, which can lead to premature delivery, adding the complications associated with preterm birth to the congenital problem the baby already has.
“The ChorioAnchor has the potential to reduce these complications by providing mechanical support to the chorioamniotic membranes following fetal surgery, thus reducing the risk for chorioamniotic separation and PPROM,” said Dr. Espinoza. “The additional support from the NICHD in the form of a Phase II SBIR grant will significantly help in refining the ChorioAnchor device with the objective of obtaining an investigational device exemption (IDE) from the FDA to evaluate the efficacy and safety of the device in fetal surgeries.”
Fetal surgery is rapidly growing but remains a small field with few procedures. Fannin plans to apply for Humanitarian Device Exemption (HDE) from the FDA since there are currently less than 8,000 fetal surgeries performed per year. By reducing complications, ChorioAnchor will help expand the range of congenital anomalies and conditions that are potentially treatable by fetal surgery.
“We are honored to be working with a team that has sincere dedication to improve fetal healthcare,” said Dr. Duncan Maitland, the lead collaborator from Texas A&M University.
“We are excited by this technology’s promise to make life-saving fetal surgery available to many more patients,” said Dr. Atul Varadhachary, Principal Investigator on the grant and Managing Director at Fannin Innovation Studio. “The unique IP3 collaboration allows us to develop novel pediatric devices, like the ChorioAnchor, that address major unmet needs but are commercially unattractive to traditional device investors due to the small market size.”
Fannin and its IP3 partners will execute the Phase II SBIR grant over the next two years, to develop a finalized device for pre-clinical and clinical testing. If successful, this device will have a significant impact on the field of fetal surgery.
About Fannin Innovation Studio
Houston-based Fannin Innovation Studio is an early-stage life sciences development group focused exclusively on commercializing biotech and medtech technologies. Fannin partners with life science innovators to create startup companies, providing management, funding, and business development. To further bridge the commercialization gap, Fannin’s fellowship and internship programs provide aspiring entrepreneurs with hands-on development experience with its portfolio companies. For more information, visit www.FanninInnovation.com, come by the Studio at 3900 Essex Lane -- Suite 575 in Houston, or email us at firstname.lastname@example.org.
About Innovation Partnership for Pediatric Products
The Innovation Partnership for Pediatric Products (IP3) is an agreement between Fannin Innovation Studio, Texas Children’s Hospital (TCH), and Baylor College of Medicine (BCM) with the primary goal of creating and commercializing medical devices specifically designed for children. Since pediatric markets are small, it can be commercially unattractive to develop medical devices specifically for pediatric indications. IP3 addresses this problem by creating a mechanism to de-risk the earliest stages of pediatric device development and enable the commercialization of pediatric medical devices. IP3 provides an interesting example of Fannin’s ability to pursue opportunities that may not be accessible through traditional VC-funded medical device startups due to the Studio’s capital-efficiency and Fannin’s close relationships with institutions in Houston’s medical center, including TCH and BCM.
About Texas Children’s Hospital
Texas Children’s Hospital, a not-for-profit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education, and research. Consistently ranked as the best children’s hospital in Texas, and among the top in the nation, Texas Children’s has garnered widespread recognition for its expertise and breakthroughs in pediatric and women’s health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Tower for pediatric research; Texas Children’s Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children’s Hospital West Campus, a community hospital in suburban West Houston; and Texas Children’s Hospital The Woodlands, the first hospital devoted to children’s care for communities north of Houston. The organization also created Texas Children’s Health Plan, the nation’s first HMO for children; has the largest pediatric primary care network in the country, Texas Children’s Pediatrics; Texas Children’s Urgent Care clinics that specialize in after-hours care tailored specifically for children; and a global health program that’s channeling care to children and women all over the world. Texas Children’s Hospital is affiliated with Baylor College of Medicine.
TX Fannin Innovation Studio 宣布，与得克萨斯儿童医院合作，从国立卫生研究院 Eunice Kennedy Shriver 儿童健康与人类发展研究所收到一笔200万美元的第二期小企业创新研究赠款，用于开发 ChorioAnchohor 设备，贝勒医学院和德克萨斯农工大学.
ChorioAnchohor 装置的设计是为了帮助母胎外科医生减少早产和通常与胎儿手术相关的感染的风险。每年有120,000多名婴儿出生有胎儿缺陷，其中50,000名可能在产前得到修复。这些缺陷影响了生活质量，并要求医院住院，估计每年花费医疗保健系统230亿美元。2011年里程碑式的 MOMS 试验证明了脊柱裂患者的胎儿手术的好处及其在其他条件下的潜在应用。
ChorioAnchor 项目是儿科产品创新伙伴关系( IP3)的一部分，这是德克萨斯儿童/儿童医学中心、 TAMU 和 Fannin 之间独特的三方伙伴关系，用于开发新型儿科设备。德克萨斯州儿童/儿童医学中心的母胎外科医生。Jimmy Espinoza 和 Michael Belfort 认识到这一方法未得到满足的需要和构想。在 Balakrishna Haridas 博士的指导下， TAMU 的一个高级设计团队和研究生开发并迭代早期原型。范宁领导了该项目的开发和资助，包括2017年成功的第一阶段 SBIR 赠款，随后是最近的第二阶段奖。
虽然胎儿外科的学科相对较新，但已投入大量的合作努力和资源，以确定可能从胎儿干预措施中受益的胎儿条件。然而，这些努力受到与这些干预措施有关的风险的阻碍，包括膜的早产破裂（ PPROM ）和早产。任何胎儿手术最常见的并发症是 PPROM ，这可能导致早产，增加与早产相关的并发症的先天性问题婴儿已经。
“ ChorioAnchohor 有潜力通过在胎儿手术后为绒毛膜提供机械支持来减少这些并发症，从而降低绒毛膜分离和 PPROM 的风险，” Espinoza 博士说。“ NICHD 以 II 期 SBIR 拨款的形式提供的额外支持将显著有助于改善 ChorioAnchor 设备，目的是从 FDA 获得研究设备豁免（ IDE ），以评估该设备在胎儿手术中的有效性和安全性。”
胎儿手术正在迅速发展，但仍然是一个小领域，几乎没有程序。范宁计划向 FDA 申请人道主义器械豁免（ HDE ），因为目前每年进行的胎儿手术不到8000次。通过减少并发症， chorioAnchohor 将有助于扩大先天性异常的范围和条件，潜在可治疗胎儿手术。
“我们很荣幸能与一个致力于改善胎儿保健的团队合作，”德克萨斯 A & M 大学的首席合作者邓肯·梅特兰博士说。
Fannin Innovation Studio 的首席研究员兼董事总经理 Atul Varadachary 博士说：“这项技术承诺将为更多的患者提供挽救生命的胎儿手术，我们对此感到兴奋。”“ IP3的独特合作使我们能够开发新的儿科设备，如 ChorioAnchor ，满足主要未满足的需求，但由于市场规模较小，在商业上对传统设备投资者没有吸引力。”
Fannin 及其 IP3合作伙伴将在未来两年内执行 II 期 SBIR 的资助，以开发一个用于临床前和临床测试的最终设备。如果成功，该装置将对胎儿外科领域产生重大影响。
总部位于休斯顿的范宁创新工作室是一个早期生命科学发展小组，专门致力于生物技术和医疗技术的商业化。范宁与生命科学的创新者合作创建创业公司，提供管理、资金和业务发展。为了进一步缩小商业化差距，范宁的奖学金和实习项目为有抱负的企业家提供了其投资组合公司的实践开发经验。有关更多信息，请访问 www.FanninInnovation.com ，该网站由位于休斯顿的 Essex Lane - Suite 575的工作室提供，或通过电子邮件发送至 innovation @ fanninInnovation.com 。
儿科产品创新伙伴关系（ IP3）是德克萨斯州儿童医院 Fannin Innovation Studio 和 Baylor 医学院（ BCM ）达成的一项协议，其主要目标是创造和商业化专门为儿童设计的医疗设备。由于儿科市场规模较小，开发专门用于儿科适应症的医疗器械在商业上不具吸引力。IP3通过创建一种机制来解决这一问题，该机制可以降低儿童设备开发的早期阶段的风险，并使儿童医疗设备商业化。IP3提供了一个有趣的例子，说明范宁有能力寻求传统风险投资资助的医疗设备初创公司无法获得的机会，因为 Studio 的资本效率和范宁与休斯顿医疗中心（包括 TCH 和 BCM ）等机构的密切关系。
德克萨斯儿童医院，一个非营利性的医疗保健组织，致力于创造一个健康的未来，为儿童和妇女在全球社会，领导在病人护理，教育和研究。德克萨斯州儿童医院一直被评为德克萨斯州最好的儿童医院，也是全美最好的儿童医院之一，德克萨斯州儿童医院因其在儿童和妇女健康方面的专业知识和突破而获得广泛认可。该医院包括 Jan 和 Dan Duncan 神经病学研究所、 Feinn 儿科研究大楼、 Texas Children's Pavilion for Women ，这是一个综合的产科/妇科设施，重点是高风险的分娩；德克萨斯儿童医院西校区。休斯敦西部郊区的一家社区医院；以及德克萨斯儿童医院林地，这是第一家专门为休斯顿北部社区提供儿童护理的医院。该组织还创建了德克萨斯州儿童健康计划( Texas Children's Health Plan )，这是全国首个儿童健康组织( HMO )，拥有全国最大的儿童初级保健网络。德州儿童儿科；德克萨斯儿童紧急护理诊所，专门为儿童量身定制的课后护理；以及一个全球健康计划，该计划引导全世界儿童和妇女的护理。德克萨斯儿童医院隶属贝勒医学院。