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Friday, March 15, 2019

Siemens Healthineers to construct digital healthcare ecosystem in China

The 2019 Digital Healthcare Forum, jointly hosted by China International Medical Foundation and Siemens Healthineers, was held in Beijng.
Siemens Healthineers will continuously provide innovative digital healthcare solutions, aiming further to build up a digital healthcare ecosystem and fulfill its corporate commitment of digitalizing healthcare.
The healthcare company signed the memorandum of understanding with TencentMedical, Deepwise, Infervision and ZHU to promote the development of a digital healthcare ecosystem in China.
“Our aspiration is to shape the future of healthcare by expanding precision medicine, transforming care delivery, and improving patient experience, all enabled by digitalizing healthcare,” said Bernd Montag, CEO of Siemens Healthineers.
“Considering the challenges of an aging population and the need to reduce costs, the digital transformation of healthcare is crucial to come to solutions. Siemens Healthineersis willing to work with companies in the healthcare industry to build up a digital healthcare ecosystem, promote the development and application of the healthcare big data and artificial intelligence in the field of medical diagnostics and treatment. China is one of the most important markets for Siemens Healthineers, and we are looking forward to bringing together our resources with local expertise to commonly contribute to the development of healthcare in China,” he said.
Siemens Healthineers believes the future of healthcare will be more personalized and result oriented. The company deploys healthcare digitalization to realize generation, aggregation, and analysis of medical imaging data to enable healthcare providers to increase value during the journey of healthcare industry transformation.
“In the past two decades, Siemens Healthineers has achieved a series of significant results in AI: more than 500 patents in the field of machine learning, more than 100 basic patents in the field of deep learning, and more than 40 AI-powered products,” Bernd Montag said, “teamplay is a significant cornerstone of Siemens Healthineers’layout of a digital healthcare ecosystem. Through this open innovative platform, AI+imaging applications, such as lung nodule image-assisted diagnosis and cancer screening are available, so that we’re able to provide users with convenient, efficient and diversified solutions. It’s like APP store in digital healthcare area.”
Siemens Healthineers’ teamplay, a cloud-based big data platform, which is the core of its digital healthcare ecosystem will effectively improve the operational efficiency of medical institutions, and also create synergy of the entire industry chain to meet the challenges faced by China’s healthcare industry.
“Teamplay has already applied in Europe and the US to optimize clinical operations. We are looking forward to help expanding precision medicine, improving radiologist’s working efficiency, optimizing clinical management in China by teamplay. Actually, Chinais far beyond a market for us. China is our home.” he added.
Jerry Wang, President of Siemens Healthineers Greater China said: “Healthcare is among the first four key areas of AI applications in China. The eco-system, as an significant step in implementing a digitalization strategy, is a crucial effort of Siemens Healthineers to respond to the country’s innovation-driven development strategy and support the medical reform and primary healthcare construction. We hope to improve the efficiency of medical resources, lower healthcare costs, ease the harsh situation of ‘difficult and expensive to see a doctor’, and enable quality medical services to benefit more people. ”
More than 150 leaders and experts from government, industry associations, medical institutions, and companies like AliHealth, Ping An Good Doctor, and Tencent Medical, got together to discuss healthcare digitalization worldwide.
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LivaNova to Present Autonomic Regulation Findings for Heart Failure

LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today announced it will present three abstracts supporting the use of implantable neuromodulation technology to treat chronic heart failure during the American College of Cardiology 68th Annual Scientific Session (ACC 2019) from March 16-18 in New Orleans, USA.
The LivaNova VITARIA® System delivers Autonomic Regulation Therapy (ART) using Vagus Nerve Stimulation (VNS) to treat patients with chronic, symptomatic heart failure with reduced ejection fraction (HFrEF). VITARIA is currently being used to study the effects of ART in a prospective, international, randomized, controlled clinical trial (ANTHEM-HFrEF Pivotal Study). Patients meeting all inclusion and exclusion criteria are randomized (2:1) to either the treatment arm or the control arm, and are followed thereafter to determine the safety and efficacy of the system and therapy.
The VITARIA System has received Expedited Access Pathway designation as a Breakthrough Technology from the U.S. Food and Drug Administration. If approved, the VITARIA System could be the first in its class for treating chronic heart failure.
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Sutro Initiates Phase I Trial for Ovarian, Endometrial Cancer Treatment

Sutro Biopharma, Inc. (NASDAQ: STRO) today announced that it has dosed the first patient in a Phase I study of STRO-002, an anti-folate receptor alpha (FoIRα) antibody-drug conjugate (ADC), in patients with ovarian and endometrial cancers. This is the second product candidate to be evaluated in clinical trials resulting from Sutro’s XpressCF+™ technology platform.
The study is a multi-center, open-label, dose-escalation with dose expansion Phase I trial evaluating the safety, tolerability and preliminary anti-tumor activity of STRO-002. The study plans to enroll up to 160 women with advanced relapsed and/or progressive ovarian, fallopian, primary peritoneal or endometrial cancer.
“Moving our second product candidate into human clinical trials is another momentous milestone in Sutro’s evolution from a technology platform company to a clinical stage company,” said Sutro CEO Bill Newell. “Our goal is to ultimately help fill the unmet need for more targeted therapies for patients with ovarian and endometrial cancer and advancing STRO-002 into the clinic brings us one step closer to achieving this.”
STRO-002 is designed to target FoIRα, a cell-surface protein highly expressed in ovarian cancer. In preclinical studies, STRO-002 demonstrated potent in vitro cytotoxicity in ovarian cancer cell lines and significantly inhibited tumor growth in multiple ovarian cancer xenograft models. In safety studies conducted in non-human primates, STRO-002 was well tolerated at clinically relevant doses. “Based on observations from pre-clinical studies, STRO-002 has the potential to overcome traditional dose-limiting factors in the clinical setting, including ocular toxicity, which is a vexing problem with some ADCs,” said Sutro Chief Medical Officer, Arturo Molina, M.D.
Denise Uyar, M.D., Associate Professor of Gynecology Oncology at Medical College of Wisconsin, an investigator in the STRO-002 study added, “Sutro’s unique ADC has the potential to be another important therapeutic option for oncologists in treating patients with ovarian and endometrial cancer. We look forward to evaluating the next-generation of ADCs in this study.”
The Phase I study will consist of two parts: dose-escalation followed by dose-expansion. In both parts of the study, STRO-002 will be dosed as an intravenous infusion on Day 1 of 21-day cycles. Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT03748186.
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Catasys earnings, revenue, guidance beat views

Catasys (NASDAQ: CATS) reported Q4 EPS of ($0.09), $0.17 better than the analyst estimate of ($0.26). Revenue for the quarter came in at $5.6 million versus the consensus estimate of $4.89 million.
  • Q4 2018 Record Revenue of $5.6 Million, up 85.3% Year over Year and Up 28.7% from Q3 2018
  • YE 2018 Record Revenue of $15.2 Million, Up 96.7% from YE 2017
  • Outreach Pool of Eligible Members Increased to approximately 75,000 Members at March 1, 2019 (up 97% from 38,000 at Q3 2018) as a Result of Significant Expansion within Existing Plans
  • Reiterates 2019 GAAP Revenue Guidance of $35 Million
  • Company to Host Conference Call at 4:30 pm ET on March 14, 2019
Mr. Terren Peizer, Chairman and CEO, stated, “Catasys has had a strong start to 2019, as continued expansions with existing health plan partners significantly accelerated our outreach pool of eligible members to record levels. The signing of contracts with new health plans, launches in new states, and program expansions led to solid enrollment growth for the Company in 2018. We are reiterating our previous guidance of $35 million of revenues for 2019, which we believe is a conservative estimation of this enrollment trend given the sizable increase in our outreach pool.”
Catasys’ outreach pool of eligible members continued its rapid ramp, increasing to current levels at March 1, 2019 of 75,000 due to significant expansion within existing contracts, an increase from approximately 41,000 at December 31, 2018 and up from 38,000 at the end of the third quarter of 2018. New customer launches continue to take approximately 12 months to ramp up to an approximate 20% yearly enrollment rate. One year after launch, the Company generally enrolls more than 20% of its outreach pool over a year. Catasys generally receives approximately $6,500 net per enrolled member.
Mr. Peizer continued, “The Company continues to re-invest in our infrastructure to ensure that we are able to properly scale operations in anticipation of pending enrollment growth. We are technologically preparing to handle additional volume, and will be hiring and training additional care coaches to ensure that members of the OnTrak program continue to receive the best care while still optimizing our own productivity. Finally, we intend to devote continued time and resources to new products that utilize our existing platform and data driven analytics to widen Catasys’ potential outreach population even further. Given these positive indicators and our ability to capitalize on growth opportunities, we remain confident that our provided guidance is a conservative floor for this year.”
GUIDANCE:
Catasys sees FY2019 revenue of $35 million, versus the consensus of $34.63 million.

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Soleno up on continuation of DCCR study

Thinly traded nano cap Soleno Therapeutics (NASDAQ:SLNO) is up 44% premarket on robust volume in response to the continuation of its Phase 3 clinical trial, DESTINY, evaluating diazoxide choline controlled release (DCCR) in patients with Prader-Willi syndrome (PWS), a Fast Track-designated indication in the U.S. and Orphan Drug indication in the U.S. and Europe. The independent Data Safety Monitoring Board recommended that the study continue without modification, further supporting DCCR’s safety profile.
The primary endpoint is the change from baseline in hyperphagia score at week 13 (hyperphagia is an abnormally increased appetite that results in excessive eating and obesity).
The company adds that patients who have completed treatment in DESTINY continue to roll over into a nine-month open-label extension study.
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Wedbush views Karyopharm ‘s PDUFA date extension as a positive

Wedbush analyst David Nierengarten maintained an Outperform rating and $6 price target on Karyopharm. In a note titled “FDA Extends PDUFA by Three Months,” he said he is inclined to view the extension as a positive for the company “given the negative sentiment on the name and general belief that an April 6, 2019 approval was unlikely.”
https://thefly.com/landingPageNews.php?id=2879891

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J&J talc risk more than accounted for in current valuation, says Credit Suisse

Credit Suisse analyst Vamil Divan said a $29M jury award to a woman who claimed that asbestos in baby powder led to her development of mesothelioma has brought potential litigation risk for Johnson & Johnson back into the headlines. However, he spoke to Johnson & Johnson and they remain confident in the safety of their product, stating that they plan to appeal and feel there were serious procedural and evidentiary errors made in the trial. Divan, who believes the potential risk from talc cases has been “more than sufficiently accounted for” in the current valuation of J&J shares, also thinks that multiple ongoing cases will hopefully lead to more clarity soon. He keeps an Outperform rating on Johnson & Johnson shares.
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