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Nobelpharma America Announces Presence at 2021 Society for Pediatric Dermatology Annual Meeting

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BETHESDA, Md., July 6, 2021 /PRNewswire/ — Nobelpharma America, LLC, a pharmaceutical and medical device company headquartered in Bethesda, Maryland, today announced its involvement at the 2021 Society for Pediatric Dermatology (SPD) Annual Meeting July 8-10, 2021. The company will provide a virtual booth and present a scientific poster during the virtual conference. This will be the company’s second year attending the meeting.

“We’re excited to attend the largest pediatric dermatology conference for the second year in a row, so we can provide a voice for underserved patient populations such as those living with facial angiofibroma associated with tuberous sclerosis complex (TSC),” said Yoshiki Kida, President & CEO of Nobelpharma America. “Approximately 50,000 people in the U.S. have TSC-related facial angiofibroma. Our presence at the SPD annual meeting enables us to have crucial conversations with the doctors who are at the forefront of diagnosing and treating this disease.”

Further details around Nobelpharma America’s participation and other related upcoming events can be found below.

Poster Presentation

Nobelpharma America will present a scientific poster as part of its involvement within the conference. The data presented is a sub analysis of the poster presentations the company displayed at the 2020 SPD Annual Meeting and relates to the impact of facial angiofibroma on patients living with TSC and management of symptoms. The related abstract provides a retrospective analysis of the Natural History Database maintained by the TSC Alliance and will be presented by Dr. Eric Beresford, Head of Medical Affairs at Nobelpharma America. For more information and to register for the 2021 Society of Pediatric Dermatology Annual Meeting, visit https://pedsderm.net/meetings/annual-meeting/registration/.

Other Upcoming Events – Fireside Chat

Nobelpharma America will host a virtual Fireside Chat related to the impact of facial angiofibroma on patients living with TSC. The Fireside Chat will take place on July 14, 2021 from 7 – 9 p.m., ET. The conversation will feature a panel of experts, including pediatric dermatologists, neurologists, psychiatrists, leaders in TSC advocacy and individuals with TSC. The focus will be both on the sociological and clinical aspects of individuals with TSC and facial angiofibroma. To learn more about the Fireside Chat, please contact us at, FiresideChat@MedEvoke.com.  Attendees will be able to submit questions addressed to the expert panel during the program.

About Tuberous Sclerosis Complex (TSC):

TSC is a rare genetic disease that affects approximately one in 6,000 live births. Nearly one million people worldwide are estimated to have TSC, with approximately 50,000 in the United States. TSC causes non-cancerous tumors, or hamartomas, to form in vital organs including the skin. TSC may also cause facial angiofibromas, which are pink or red bumps usually located on the cheeks, nose, and chin that may cause bleeding, itching, redness, and significant disfiguration without treatment. Many individuals with TSC also present with autism, epilepsy, and other neuropsychiatric disorders.

About Nobelpharma America
Nobelpharma America, LLC (NPA) is focused on the commercialization of pharmaceuticals and medical devices that expand treatment options for people with rare diseases. In 2019, NPA became the first wholly owned global subsidiary of Nobelpharma Co., Ltd., which is based in Tokyo. The company, which is named after Alfred Nobel, remains committed to honoring his innovative and scientific legacy by developing treatments for diseases that often go overlooked because of the small number of individuals affected. For more information visit nobelpharma-us.com.

Cision View original content:https://www.prnewswire.com/news-releases/nobelpharma-america-announces-presence-at-2021-society-for-pediatric-dermatology-annual-meeting-301325189.html

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Dice’s IPO roll comes up with $204M for R&D of oral drugs to rival biologics

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Biologic drugs offer quite the punch, treating a wide swath of immunological disorders for patients while bringing in blockbuster sales for drug companies. But these large molecules come as injections or infusions. Dice Therapeutics believes it can address the patient preference for pills by developing small molecule drugs that can hit large molecule targets. The concept has won over investors, enabling the preclinical-stage biotech to raise $204 million in an upsized IPO.

Dice Therapeutics, which changed its name from Dice Molecules ahead of the IPO, initially planned to offer 10 million shares in the range of $15 to $17 apiece. The company boosted the number of shares in the deal to 12 million and offered them at the top of the projected price range. Dice’s shares began trading on the Nasdaq Wednesday under the stock symbol “DICE.”

In its IPO filing, Dice notes that biologic drugs developed in the late 1990s and early 2000s transformed the treatment of many immunological disorders. But the company added that improvements to the efficacy of these drugs and how frequently they must be dosed still poses a hurdle to patients who don’t want chronic injections or infusions. Developing oral versions of these drugs has been its own challenge, as large molecules such as antibodies can’t be absorbed in the gut.

Dice’s proprietary technology, called Delscape, discovers, designs, and develops small molecules that it says have the potential to modulate protein-protein interactions as effectively as large molecules do. The company is developing drugs that go after disease targets that have already been validated for biologic drugs, but the company aims to hit those targets with its small molecules.

Lead Dice drug candidate S011806 is designed to block interleukin-17, a pro-inflammatory signaling molecule. Biologic drugs that address this target include two antibodies: Novartis’s Cosentyx and Taltz from Eli Lilly. Those drugs, each approved for multiple immunological disorders, generated about $4 billion and $1.8 billion respectively in revenue last year. In preclinical research, Dice said its small molecule was able to selectively block forms of IL-17 and also match the anti-inflammatory activity of a monoclonal antibody. Now the company aims to see how well its animal research translates to humans.

In July, Dice filed a clinical trial application seeking permission to begin human testing of S011806 in the United Kingdom. The company said in the IPO filing that it plans to start a Phase 1 study in healthy volunteers, followed by a Phase 1c clinical trial in patients with psoriasis. Programs in inflammatory bowel disease and idiopathic pulmonary fibrosis are in earlier stages of development with drug candidates yet to be nominated. Other drug targets include interleukin-23, tumor necrosis factor alpha, neonatal Fc receptor, and thymic stromal lymphopoietin.

Dice is keeping immunology as the main focus of the company’s internal programs. Expansion into other therapeutic is happening via research partnerships. In 2015, Dice began an immuno-oncology research partnership with Sanofi that gives the phama giant an exclusive option to license, develop, and commercialize compounds that Dice discovers. If Sanofi opts to develop compounds discovered under the alliance, the French company could be responsible for paying its partner up to $200 million tied to development and regulatory milestones, plus royalties from sales of a commercialized product.
Dice said in the IPO filing that this research has identified multiple potential drug candidates, and an investigational new drug application is expected by the end of 2023.

A partnership Dice inked with Genentech in 2017 has not gone as well. The alliance covered targets selected by the Roche subsidiary. Details about those targets were not disclosed but apparently Genentech did not see anything that from Dice that  it liked. As of the end of 2020, Genentech had not requested additional research services nor had it selected any of the customer options available under the contract, Dice said in the filing.

Prior to the IPO, Dice had raised about $200 million, according to the prospectus. The largest shareholder after the IPO is RA Capital Management, owning 11.1% of the company followed by Northpond Ventures’ 8.9% stake.

As of June 30, Dice reported a cash position of $42.5 million. Combined with the IPO proceeds, the company plans to spend about $90 million for its lead program, S011806, and another $20 million on its programs for inflammatory bowel disease and idiopathic pulmonary fibrosis. The rest of the IPO cash will go toward other research and development work.

After IPO, Tyra Bio aims to make cancer drug R&D a “SNAP”

Tyra Biosciences, a cancer drug developer, raised $172.8 million from its IPO to bring its most advanced programs into clinical trials. After initially planning to offer 9 million shares in the range of $14 to $16 each, the company found investor interest was strong enough to support increasing the number of shares to 10.8 million, which were offered at the top end of the projected price range. Shares of Carlsbad, California-based Tyra trade on the Nasdaq under the stock symbol “TYRA.”

Despite the availability of new targeted cancer treatments, the response rate and the duration of currently available therapies can be limited by drug resistance and other shortcomings, Tyra said in its IPO filing. Tyra’s technology, called SNAP, yields small molecules specifically designed to address acquired drug resistance.

According to the prospectus, SNAP efficiently identifies and selectively targets vulnerabilities in mutant proteins where genetic alterations have eliminated or reduced the effectiveness of targeted therapies. These “SNAPshots” give insight into the structure of binding sites for its molecules, telling Tyra scientists how commonly occurring genetic alterations lead to acquired drug resistance to existing drugs. With those insights into the genetic alterations most likely to cause drug resistance, the company designs drug candidates that avoid those mutations but still block the intended target.

“Through this process, we identify product candidates that may have the potency and selectivity to, if approved, be used as important treatment options to address critical unmet needs,” Tyra said in the prospectus.

The first focus of Tyra is developing small molecules that block fibroblast growth factor receptors (FGFR), a family of proteins that when mutated, drive cancer growth. Lead Tyra program TYRA-300 is designed to block FGFR3; the initial focus for that compound is bladder cancer. The company plans to submit an investigational new drug application in the middle of 2022. Other drugs in the pipeline include compounds targeting FGFR2, FGFR3, RET, and FGFR4.

Before the IPO, Tyra had raised $157.2 million, the company said in the IPO filing, most recently a $106 million Series B financing announced in March. The largest shareholders are RA Capital Management and Boxer Capital, each holding a 15.3% post-IPO stake. As of June 30, the company reported having $135.2 million in cash. In the IPO filing, Tyra said it plans to spend $18.9 million for development of TYRA-300 through the completion of the Phase 1 portion of the planned Phase 1/2 clinical trial. Another $19.4 million is set aside for developing the FGFR2 program, also through completion of Phase 1; about $20.8 million will go to advance the FDFR3 program for achondroplasia into the clinic. The rest of the IPO cash will be used for discovery and preclinical development of other drug candidates.

Procept and its surgical robot score $164M in stock market debut

Procept BioRobotics, a company that was awarded FDA marketing clearance for its surgical robot earlier this year, raised $163.9 million to support its ongoing commercialization efforts. The Redwood City, California-based company was able to boost the size of its IPO. After initially planning to offer 5.5 million shares in the range of $22 to $24 each, Procept ended up offering more than 6.5 million shares at $25 apiece. Those shares trade on the Nasdaq under the stock symbol “PRCT.”

The Procept robot, called the AquaBeam Robotic System, was developed to enable minimally invasive urologic surgery, removing prostate tissue in patients who have benign prostatic hyperplasia, or BPH. Development of the technology began in 2009, according to the IPO filing. The robotic system’s features include real-time imaging; ultrasound imaging integrated with planning software that helps the surgeon come up with a tissue removal plan specific to the patient’s anatomy; robotic execution of the procedure under the watch of the surgeon; and ablation of the unwanted tissue using a heat-free water jet that pulses at nearly the speed of sound.

AquaBeam was first commercialized overseas; the FDA granted marketing clearance to the Class II medical device in March, according to the IPO filing. Through the end of June, Procept said it had 124 of its systems installed globally and 73 in the U.S. So far, AquaBeam has been used to treat more than 5,500 patients. Procept reported $7.7 million in sales in 2020, a more than 26% increase over the prior year. Sales continue to grow. Revenue in the first half of this year was nearly double the company’s total sales in 2020. With the IPO proceeds, Procept said it plans to spend $45 million to hire more sales and marketing staff; another $25 million is set aside for product development and R&D.

Photo: Sezeryadigar, Getty Images

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Source: https://medcitynews.com/2021/09/dices-ipo-roll-comes-up-with-204m-for-rd-of-oral-drugs-to-rival-biologics/

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Croom Medical Surges Ahead With Cutting-Edge Additive Manufacturing Technology

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Over 20,000 Metallic Additive Implants Produced

(Limerick, Ireland) – Croom Medical has produced over 20,000 Additive Implants as of September 2021 at its Additive Manufacturing center of excellence. The company has invested over €10.2million in its plant and machinery over the past 24 months alone where additive manufacturing is a key pillar for the company’s technology driven strategy.

As an industry leader in utilizing high-tech, high-growth, cutting-edge medical device manufacturing technology, Croom Medical has over 37 years’ experience in partnering with global healthcare companies as an outsourced manufacturing service of high precision components and medical devices. Founded in 1984, Croom Medical’s quality team has been paramount to the recent success of multiple 510k submissions hosting additive implants on behalf of its global customer base.

‘’We started our metallic additive journey in 2008 where we aligned ourselves with industry and academic partners. The strategic technology driver for our business here was the market intelligence gained by our research, development and innovation (RDI) team. Our RDI and Quality team have really been the backbone to this technology success for us here in Croom. They have consistently gone above and beyond in collaborating with our OEM customer base on developing a cost competitive additive manufacturing process that meets all morphological, chemistry and mechanical ASTM standards. We have recently invested in an in-house metallurgical lab that will add further value to our operations. With a number of powder bed fusion systems on site, we are looking at EBM and heat treatment processes which will further augment our value add in 2022.’’ Patrick Byrnes, CEO at Croom Medical.

Croom Medical hosts a skilled team of 80 who are steeped in the advanced machining and manufacture of orthopedic implants and instruments. Aside from lights out 5-Axis Machining and a number of sliding heads, the company has also invested over €1.6million in a state of the art drag finishing system for its implant production. In addition, Croom Medical hosts nondestructive testing, 5-Axis CNC Grinding, Intermediate Clean Lines, Hand Finishing Cells, Heat Treatment, Metrology Lab and Toolroom capabilities.  

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About Croom Precision Medical

Croom Precision are an FDA registered company that offers OEM contract manufacturing and engineering services to medical device companies. For over 37 years, we have offered high quality medical components to our customers and work continuously to deliver the most cost-effective solutions.

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Source: https://www.biospace.com/article/croom-medical-surges-ahead-with-cutting-edge-additive-manufacturing-technology/?s=93

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Rhaeos, Inc. Awarded $4 Million NIH SBIR Grant to Expand Quantitative Measurement Capabilities of its FlowSense™ Noninvasive Wireless Sensor

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EVANSTON, Ill., Sept. 16, 2021 /PRNewswire/ — Rhaeos, Inc., a private medical device company focused on the care of patients with hydrocephalus, announced today it was awarded a $4 million, multi-year grant from the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program through the National Institute of Neurological Disorders and Stroke (NINDS). Grant funds will be used to expand the functionality of its FlowSense wireless noninvasive sensor to provide flow rate measurements and other quantitative data.

The SBIR grant advances Rhaeos’ development of wearable sensors to detect failed shunts in patients with hydrocephalus.

Designed to rapidly monitor ventricular shunt function in patients with hydrocephalus – a term for excess cerebrospinal fluid (CSF) that affects more than 1 million adults and children in the U.S. – FlowSense is a noninvasive wireless sensor that adheres to a patient’s skin above the implanted shunt tubing. Critical data on shunt functionality is measured in a matter of minutes and wirelessly transmitted to a mobile app to improve clinical decision making.

Under the NIH SBIR grant, Rhaeos will leverage their existing wireless sensor hardware to provide additional quantitative flow data to the clinician, giving insight into this currently inaccessible and highly relevant shunt performance metric. The grant will support substantial animal model validation, advanced algorithm development, and multi-center clinical investigations that will ultimately lead to a marketing submission to the FDA.

“Shunts are life-saving devices for patients with hydrocephalus, but the reality is that the tools we have today to assess their functionality are very limited,” said David D. Limbrick, Jr., MD, PhD, T.S. Park Chair and Chief of Pediatric Neurosurgery at Washington University School of Medicine, and Neurosurgeon-in-Chief with St. Louis Children’s Hospital. “I am delighted to be part of the research team focused on developing this important new device. Rhaeos’s FlowSense is poised to dramatically impact care of these patients by reducing the number of evaluation assessments and, potentially, surgeries required to manage a highly complex, lifelong disease.”

Dr. Limbrick, who is active within the Hydrocephalus Clinical Research Network, and James McAllister, PhD, Professor of Neurosurgery at the Washington University School of Medicine, are investigators on the NIH SBIR grant.

About half of all implanted shunts – the standard approach to managing hydrocephalus – fail within the first two years of placement and require repeated surgical intervention. Failure is typically diagnosed by computed tomography (CT) and magnetic resonance imaging (MRI), which can be inconclusive and expensive. The ability to directly measure flow dynamics addresses this crucial care gap by enabling point-of-care diagnostics of shunt function.

“One of the most frustrating and worrisome aspects of managing hydrocephalus for both patients and physicians is not knowing with certainty if an implanted shunt is working,” said Co-Investigator Matthew B. Potts, MD, a Cerebrovascular Neurosurgeon with Northwestern University Feinberg School of Medicine’s Division of Cerebrovascular/Neurointerventional Surgery in the Department of Neurological Surgery. “This device has the potential to give us an immediate, direct way of confirming if a shunt is functioning properly. With the backing of the NIH SBIR grant, we can compress the development timeframe and move to clinical trials more rapidly than would otherwise be possible.”

The current grant brings the total SBIR funds awarded to Rhaeos in 2021 to over $5 million. Earlier this year, they also received $1.19 million from the National Science Foundation for development of a remote monitoring version of FlowSense that will allow the company to offer a full suite of shunt monitoring solutions that can follow hydrocephalus patients from hospital to home.

“This NIH SBIR grant is an important milestone in Rhaeos’s commitment to developing wearable sensors to improve the care of patients suffering from hydrocephalus and, eventually, other chronic, complex conditions,” said Anna Lisa Somera, MS, MBA, MPH, the CEO of Rhaeos. “We look forward to advancing the important work of identifying and developing safer, more reliable methods for detecting and managing failed shunts and providing patients with the peace of mind of knowing when their shunt is functioning as intended.”

About Rhaeos, Inc.
Rhaeos, Inc. is a private, clinical stage medical device company, formed out of the award-winning John A. Rogers Research Group at Northwestern University, focused on developing wearable sensors to improve care of patients suffering from chronic and difficult-to-treat conditions. The company’s novel FlowSense noninvasive wireless sensor addresses a clinical unmet need for patients with hydrocephalus and is funded by the National Institute of HealthNational Science Foundation, the Pediatric Hydrocephalus Foundation, the Southwest Pediatric Device Consortium, the National Capital Consortium for Pediatric Device Innovation, the UCSF-Stanford Pediatric Device Accelerator, the West Coast Consortium for Technology & Innovation in Pediatrics, MedTech Innovator, and public, private, and institutional investors.

Cision View original content:https://www.prnewswire.com/news-releases/rhaeos-inc-awarded-4-million-nih-sbir-grant-to-expand-quantitative-measurement-capabilities-of-its-flowsense-noninvasive-wireless-sensor-301378999.html

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Cardialen Awarded $3 Million Federal Grant to Advance Therapy Designed to Treat Atrial Fibrillation for Improved Heart Failure Outcomes

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National Institutes of Health grant will support Cardialen’s development of its implantable, low-energy therapy designed to treat atrial fibrillation, a cardiac arrhythmia associated with debilitating shortness of breath, fatigue, pain, and an increased risk of stroke.

MINNEAPOLIS–(BUSINESS WIRE)– Cardialen, Inc., has been awarded a $3 million National Institutes of Health (NIH) Phase IIb SBIR grant for the development of an implantable, low-energy therapy for the cardioversion of atrial fibrillation (AF). The grant was awarded after an expert panel of cardiologists, scientists, and engineers gave the Cardialen therapy an exceptional peer review as part of a highly competitive grant process.

Professor Prash Sanders, Director of the Centre for Heart Rhythm Disorders, Adelaide Medical School, Australia, is the principal investigator of Cardialen’s MultiPulse Therapy (MPT) for AF trial. “Atrial fibrillation remains a serious arrhythmia, and additional treatment options are needed,” said Professor Sanders. “Maintaining atrial fibrillation rhythm control in heart failure patients has shown to provide significant quality of life, mortality and hospitalization benefits. Cardialen’s MultiPulse Therapy could provide another important tool for patients receiving a CRT-D device.”

Atrial fibrillation, commonly known as A-fib, is an irregular and rapid heart rate that can lead to patient discomfort and increased risk of stroke. Approximately 34 million patients suffer from this condition worldwide.1 Approximately 26% of ICD patients,2 and 36% of CRT-D patients,3 receiving an implantable cardiac defibrillator have, or will likely experience, atrial fibrillation. Cardialen seeks to provide a therapy for those patients already receiving an implantable cardiac resynchronization therapy defibrillator device.

About Cardialen

Cardialen, Inc., is a Minneapolis-based medical device company developing implantable, low-energy defibrillation and cardioversion therapy designed to treat dangerously fast heart rhythms, including ventricular tachycardia and ventricular fibrillation, in addition to treating atrial fibrillation. Cardialen’s MultiPulse Therapy™ uses a patented sequence of low-energy pulses to restore normal heart rhythm more gently than high-energy, often painful, shocks used for atrial fibrillation and ventricular fibrillation. Learn more at www.cardialen.com.

The experimental MultiPulse Therapy is not currently available for use in the United States.

References:

  1. Chugh SS, Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial fibrillation: A global burden of disease 2010 study. Circulation. 2014;129(8):837-847. doi:10.1161/CIRCULATIONAHA.113.005119
  2. Mustafa U, Dherange P, Reddy R, et al. Atrial Fibrillation Is Associated With Higher Overall Mortality in Patients With Implantable Cardioverter‐Defibrillator: A Systematic Review and Meta‐Analysis. J Am Heart Assoc. 2018;7(22). doi:10.1161/JAHA.118.010156
  3. Mustafa U, Atkins J, Mina G, et al. Outcomes of cardiac resynchronisation therapy in patients with heart failure with atrial fibrillation: A systematic review and meta-analysis of observational studies. Open Hear. 2019;6(1):1-12. doi:10.1136/openhrt-2018-000937

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