Galien week of innovation

Product: LungVision

Company: Body Vision Medical

Therapeutic Area: Pneumology

About the Product:

LungVision™ by Body Vision Medical uses AI-driven algorithms to transform 2D X-ray images from any C-arm into intraoperative 3D CT scans in real time. This enables clinicians performing diagnostic bronchoscopy to see exactly where the lesion is so that they can accurately navigate to the lesion, biopsy, and make informed clinical decisions during the procedure. Bronchoscopists can thus biopsy from smaller, more difficult-to-access lung lesions at an earlier stage, dramatically increasing the likelihood of an early diagnosis for lung cancer patients and improving odds for survival. Real-time image guidance will also prove crucial for minimally invasive localized delivery of therapeutics when they become available.

Product: SpaceOAR VUETM Hydrogel

Company: Boston Scientific Corporation

Therapeutic Area: Urology

About the Product:

SpaceOAR VUE is a fully absorbable, polyethylene glycol (PEG) based, radiopaque hydrogel used to temporarily create additional space between the prostate and rectum. The additional space between the two organs reduces the risk of patients developing radiation-related bowel, urinary, and sexual side effects caused by the dose of therapeutic radiation delivered to the tissues during the treatment of prostate cancer. SpaceOAR VUE’s radiopaque properties improve pre-treatment workflow by eliminating the need for post-implantation MR imaging as part of treatment planning, and its enhanced CT visibility improves patient positioning during each treatment fraction.

Product: GammaTile®

Company: GT Medical Technologies, Inc.

Therapeutic Area: Neurology

About the Product:

GT Medical Technologies, Inc. Determined to improve the lives of patients with brain tumors and raise the standard of care, a team of brain tumor specialists formed GT Medical Technologies and innovated GammaTile® Therapy. FDA-cleared GammaTile Surgically Targeted Radiation Therapy (STaRT) is for all types of newly diagnosed malignant tumors and recurrent brain tumors. Embedded with radiation sources, the resorbable collagen GammaTiles are implanted at the completion of brain tumor removal surgery for immediate treatment—eliminating the standard delay for external beam radiation therapy. This treatment allows patients to receive radiation therapy as they go about their daily lives, without additional trips for treatment.

Product: Guardant360 CDx

Company: Guardant Health, Inc.

Therapeutic Area: Oncology - Hematology

About the Product:
The Guardant360® CDx liquid biopsy is FDA approved for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm (cancerous tumor). The test is also approved as a companion diagnostic to identify patients with non-small cell lung cancer who may benefit from treatment with TAGRISSO® (osimertinib), RYBREVANT™ (amivantamab-vmjw), LUMAKRAS™ (sotorasib), and ENHERTU® (fam-trastuzumab deruxtecan-nxki).

Product: PYLARIFY® injection and PYLARIFY AI™

Company: Lantheus

Therapeutic Area: Internal  Medicine

About the Product:

PYLARIFY® (piflufolastat F 18) injection is an FDA approved fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue sites of disease to detect and localize sites of recurrent and/or metastatic prostate cancer. PYLARIFY AI™ is artificial intelligence medical device software developed to assist with the reading and quantification of PYLARIFY scans. The technology automatically analyzes a PSMA PET/CT image to segment anatomical regions – 51 bones and 12 soft tissue organs. This image segmentation enables automated localization, detection and quantification of potential PSMA-avid lesions in a PSMA PET/CT image, which data is then incorporated into the reporting system used by physicians.

Product: Endobronchial Ultrasound Bronchoscope (BF-UC190F)

Company: Olympus America, Inc

Therapeutic Area: Pneumology

About the Product:

The Olympus BF-UC190F EBUS Bronchoscope is equipped with ultrasound capability to visualize lymph nodes beyond the bronchial wall and determine their exact location for sampling by needle aspiration in a procedure called endobronchial ultrasound guided needle aspiration (EBUS-TBNA). Recognized by the American College of Chest Physicians as the “first best test” for the pathological staging of lung cancer, EBUS-TBNA allows physicians to obtain ample quantities of the high-quality specimens needed for a comprehensive histological analysis, a benefit for patients who may be undergoing genetic testing as part of their cancer journey.

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Product: ELUVIA^TM Drug-Eluting Vascular Stent System

Company: Boston Scientific Corporation

Therapeutic Area: Cardiovascular

About the Product:

The ELUVIA Drug Eluting Vascular Stent System was designed with an antiproliferative drug, Paclitaxel, and combination of a base polymer (PBMA) and fluoropolymer PVDF-HFP to control the dose and dura¬tion of drug release to match the restenotic process in the Superficial Femoral Artery (SFA). ELUVIA is the first and only drug-eluting technology designed to sustain drug release beyond 12 months via this polymer matrix which demonstrated superiority in clinical trial and real-world usage benefitting the healthcare system along with the patients treated. In 2020, ELUVIA was granted an exclusive add-on reimbursement payment by CMS (Centers for Medicare and Medicaid Services).

Product: VersaCross Transseptal Platform

Company: Boston Scientific | Baylis Medial

Therapeutic Area: Cardiovascular

About the Product:

The VersaCross® RF Transseptal Solution is the world’s first radiofrequency (RF) wire-based solution to percutaneous left heart access, reimagining transseptal practice for efficient and precise delivery of life-changing therapy sheaths to advance patient care. This platform improves atrial septal crossing efficacy, puncture safety and, most notably, eliminates multiple risky and non-value added catheter exchanges from the bloodstream that were routinely accepted when using conventional sharp needles for over 50 years. By unlocking procedural predictability and transforming how Electrophysiology and Structural Heart procedures are delivered, VersaCross advances the standard of patient care globally.

Product: Barostim™

Company: CVRx, Inc

Therapeutic Area: Cardiovascular

About the Product:

CVRx’s Barostim Baroreflex Activation Therapy is the first medical technology approved by the FDA that uses neuromodulation - the power of the brain and nervous system - to improve the symptoms of patients with systolic heart failure (HFrEF). Barostim is an implantable device that sends electrical pulses to baroreceptors located in the wall of the carotid artery. Baroreceptors trigger the body’s baroreflex which in turn triggers an autonomic response to the heart. The therapy is designed to restore balance to the autonomic nervous system and thereby improve the symptoms of HF. Barostim received the FDA Breakthrough Device Designation and is FDA-approved for use in HF patients in the US. It has also received the CE Mark for HF and resistant hypertension in the European Economic Area.

Product: Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent

Company: Edwards Lifesciences

Therapeutic Area: Pneumology

About the Product:

The Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) system combines the proven SAPIEN 3 transcatheter heart valve and the Alterra adaptive prestent to expand transcatheter therapy options for congenital heart valve disease patients who previously faced multiple open-heart surgeries over the course of their lives. The Alterra prestent compensates for variations in size and morphology of the right ventricular outflow tract to provide a stable landing zone for the SAPIEN 3 valve, expanding the range of patients who can now be treated with minimally invasive pulmonary valve replacement, and potentially reducing the number of invasive procedures these patients must endure.

Product: Edwards SAPIEN 3 Ultra RESILIA Transcatheter Aortic Heart Valve

Company: Edwards Lifesciences

Therapeutic Area: Cardiovascular

About the Product:

The SAPIEN 3 Ultra RESILIA combines Edwards’ 40 years of tissue expertise with the market-leading SAPIEN 3 Ultra transcatheter valve and delivers patients with severe symptomatic Aortic Stenosis crucial improvements: a less invasive alternative to surgery with the potential for a longer lasting valve. RESILIA tissue’s advanced anti-calcification technology has in recent studies demonstrated freedom from structural valve deterioration at 7 years. As one of the leading causes of SVD, addressing calcification is key to overcoming questions of TAVR durability and providing thousands of patients with the confidence to choose the therapy that fits their needs.

Product: DETOUR System

Company: ENDOLOGIX LLC

Therapeutic Area: Cardiovascular

About the Product:

PTAB with the DETOUR System offers a disruptive, novel approach to treating complex Peripheral Arterial Disease (PAD), enabling physicians to bypass lesions in the superficial femoral artery, by using stents routed through the femoral vein to restore blood flow to the leg. This approach is effective for patients with long lesions (20cm-46cm in length), those that have already undergone failed endovascular procedures, or those that may be sub-optimal candidates for open surgical bypass.

Product: FloPatch FP120

Company: Flosonics Medical

Therapeutic Area: Cardiovascular

About the Product:

FloPatch is the world’s first wireless, wearable Doppler ultrasound system designed as a simple, fast, and efficient tool for clinicians managing critically ill patients. FloPatch adheres to a patient’s neck and wirelessly transmits the carotid artery Doppler spectrum in real-time to a secure iOS mobile application via Bluetooth. The mobile application’s advanced analytics engine quantifies and displays clinically actionable measures like corrected flow time and velocity time integral. FloPatch is hands-free and can be deployed in under one minute by a single user without advanced ultrasound training. Its single-button interface controls operation and connectivity with unmatched simplicity.

Product: Optimizer® Smart Mini System

Company: Impulse Dynamics

Therapeutic Area: Cardiovascular

About the Product:

The Optimizer® Smart Mini delivers CCM® therapy to the heart, intended to improve heart contraction by sending electrical pulses to heart cells during the absolute refractory period, allowing more oxygen-rich blood to be pumped throughout the body. The treatment is indicated for HF patients having an LVEF ranging from 25 to 45% to enhance their quality of life by achieving the 6-minute hall walk and reducing HF symptoms, such as shortness of breath, fatigue, swelling, chest pain, and more. Impulse Dynamics completed numerous clinical studies and several controlled trials. CCM therapy has been published in over 120 peer-reviewed journal articles.

Research team:

• David Prutchi, PhD, Executive Vice President Chief Technology Officer
• Jason Meyers, Associate Director of Engineering and Product Development

Product: PCA 500

Company: QT Medical Inc.

Therapeutic Area: Cardiovascular

About the Product:

Product: Thoraflex HybridTM

Company: Terumo Aortic

Therapeutic Area: Cardiovascular

About the Product:

The innovation of Thoraflex Hybrid™ device is a major milestone in the treatment of patients who require a total aortic arch replacement and have significant disease of the descending thoracic aorta. This unique device allows patients to be treated anytime with a single stage procedure rather than two major invasive operations which was previously the conventional pathway for this group of patients. This type of surgery is so traumatic that a high percentage of patients died before or refused to undergo the second operation. A single stage procedure has, in turn, led to lowering the risk of major adverse events over traditional treatments.

Product: AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (IOL)

Company: Alcon, Inc.

Therapeutic Area: Ophthalmology

About the Product:

The AcrySof® IQ Vivity® lens is the first of its kind, nondiffractive extended depth of focus intraocular lens (IOL) with Alcon’s proprietary X-WAVETM technology. Vivity allows for better intermediate (working on a computer, applying makeup or shaving) and some near (reading, knitting) vision compared to what a monofocal IOL would provide. With Vivity, patients have the opportunity for more spectacle independence and lower levels of visual disturbances, such as halos and glares. By introducing Vivity, more cataract patients have been able to receive advanced IOL (ATIOLs) allowing more patients the option of correcting their vision at the time of cataract surgery. 

Product: XIPERE®

Company: Bausch + Lomb

Therapeutic Area: Ophthalmology

About the Product:

XIPERE® (triamcinolone acetonide suprachoroidal injectable suspension) is the first and only FDA-approved therapy to treat macular edema associated with uveitis. It is also the first and only therapy FDA-approved utilizing the eye’s suprachoroidal space for drug delivery, which offers unprecedented access to the back of the eye and provides targeted delivery of therapeutic agents to the retina and choroid. This innovative administration technique may potentially improve efficacy and compartmentalization of medication, limiting exposure to healthy parts of the eye. With the approval of XIPERE®, the door is now open for further exploration of the suprachoroidal space as an alternative administration route for retinal disease management.

Inventors:
Henry Edelhauser
Mark Prausnitz
Samir Patel
Vladimir Zarnitsyn

Core Research Team:
Daniel White
Glenn Noronha
Rafael Andino  
Keleigh Mahn
Brian Burke
Tom Godfrey
Shelley Hancock 

Core Commercialization Team - Clearside:
George Lazaii
Charlie Deignan
Tom Ciulla
Barbara Bauschka

Core Commercialization Team – B&L:
Yolande Barnard
Dave Fisher
Joseph Ponzo
Tom Furgal
Sagar Shah
Tom Peterson
Mary Harrell
Rob Kissling
Krista Barbour 
Helen DeCory
Kristy Marks
Joel Fein
Teresa Brevetti
Douglas Jordan
Dawnya Bieller
Krishna Kewalramani
Kirstie Cole
Dean Gass

Product: LifeVac

Company: LifeVac, LLC

Therapeutic Area: Internal Medicine

About the Product:

LifeVac is a non-invasive, non-powered portable suction device designed to save the life of a choking victim. The device works by creating a vacuum in the choking patients oral cavity. LifeVac has been known to work when all other BLS protocols have failed and has 6 peer reviewed medical journals. The device is simple to use and may be used on anyone including those in a wheelchair, pregnant, or disabled. LifeVac is capable of reducing choking statistics. With one child dying every five days and over 5000 choking deaths each year LifeVac has the potential to eliminate choking relating tragedies.

Product: The Jada^® System

Company: Organon group of companie

Therapeutic Area: Gynecology

About the Product:

Product: Tablo® Hemodialysis System

Company: Outset Medical, Inc.

Therapeutic Area: Nephrology

About the Product:

Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis. The Tablo® Hemodialysis System, FDA cleared for use from hospital to home, represents a significant technological advancement that transforms the dialysis experience for patients and simplifies it for providers. Tablo is a single enterprise solution that can be utilized across the continuum of care. The integration of water purification and on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission and a proprietary data analytics platform powering a new holistic approach to dialysis care.

Research team:
Gopi Lingam
Dean Hu
Manish Khemani
James Ritson
Doug Gallinat
Michael Hogard
Steve O. Miller
Bhavesh Patel
Johnny Bui
Travis Morgan
Lenny George
Steve M Miller
Hector Vidal
Agastya Anishetty
Shapour Golzar
Paul Bridges
Neal Vanderlaan
Tanuj Chirimar
Grego Ardley
Claire Mellin
Marc Garcia
Norman Ferrer
Charles Goodman
Sirisha Gutta
Rashmi Gaba

Product: Xenon 129 MRI Technology, with XENOVIEW™ (xenon xe 129 hyperpolarized) and HPX Hyperpolarization System

Company: Polarean

Therapeutic Area: Pneumology

About the Product:

Polarean’s Xenon 129 MRI Technology is a drug device combination comprised of XENOVIEW (xenon Xe 129 hyperpolarized) and HPX Hyperpolarization System. XENOVIEW (xenon Xe 129 hyperpolarized) is the first hyperpolarized contrast agent for MRI and is produced on site with the HPX Hyperpolarization System. This non-radioactive, non-invasive, imaging modality enables the evaluation of regional lung ventilation. With a single breath hold, XENOVIEW spatially distributes to image the smallest airways and transforms MRI into a lung ventilation imaging platform. CMS (Centers for Medicare & Medicaid Services) recently granted Polarean a reimbursement code for MRI with XENOVIEW™, effective October 1st 2023.

Product: 

Company: 

Therapeutic Area: 

About the Product:

The Elecsys AD CSF assays were developed to meet the need for an accessible, affordable, radiation-free diagnostic alternative that agrees highly with amyloid PET imaging. The test quantifies the levels of beta-Amyloid (1-42) peptide (Abeta42) and tau protein phosphorylated at amino acid 181  (p-Tau181).  These molecules are modified versions of beta-Amyloid and tau proteins whose accumulation in brain tissue in extracellular amyloid plaques and intracellular neurofibrillary tangles are the hallmarks of AD.  The Elecsys Abeta42 assay is traceable to reference materials ensuring accuracy of the Abeta42 ratio results.

Product: Solo-Dex Fascile

Company: Solo-Dex, Inc.

Therapeutic Area: Rheumatology - Orthopedics

About the Product:

The Solo-Dex Fascile, a peripheral nerve block catheter assembly, provides an elegant and revolutionary approach to manage acute pain without opioids during and after orthopedic surgery. A single operator administers the block, with total control over ultrasound imaging, catheter assembly, and drug administration. This product initiates action within minutes, delivering durable pain management without the setbacks of cognitive impairment, leakage, infections, prolonged recovery, or the need for oral opioids. Solo-Dex Fascile could significantly decrease the estimated 1.2 million deaths attributed to prescription opioid misuse in North America, reducing anesthesia-related risks and promoting safer healthcare practices.

Research team:

• Sundar Rajendran MD
• Dan Kopacz MD
• Oliver Ding

Product: Titan SGS®

Company: Standard Bariatrics, Inc.

Therapeutic Area: Gastroenterology - Hepatology

About the Product:

The Titan SGS™ gastric stapler is an instrument used for resecting and stapling the stomach during laparoscopic, robotic-assisted laparoscopic, and open surgical procedures. The Titan SGS offers a 23cm staple line, the longest in the industry, designed specifically for gastric tissue and offers a novel alternative for performing sleeve gastrectomy. It is designed to simplify visualization, reduce complexity, save time, and enable consistently optimal surgical sleeve anatomy, helping surgeons set their patients up for the best possible clinical outcomes.