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Omron pioneers new wearable heart health tech at CES

BY Michael Johnsen

Omron Healthcare on Monday unveiled breakthrough new innovations in personal heart health technology at the 2018 Consumer Electronics Show in Las Vegas. The market leader in at-home blood pressure monitors debuted two devices that represent category firsts: the Omron HeartGuide is the first wearable oscillometric wrist blood pressure monitor and the Omron Blood Pressure Monitor + EKG is the first single at-home device in the U.S. that measures blood pressure and EKG.

"The innovation and firsts we are unveiling at CES show that we are focused on – and investing in – our mission of Going for Zero, the elimination of heart attack and stroke," stated Ranndy Kellogg, Omron Healthcare president and CEO. "According to the new scientific guidelines on blood pressure, 103 million Americans are now in the hypertensive range. With these new devices, Omron Healthcare offers a range of blood pressure monitors to meet the needs and preferences of every one of them."

[quote-from-article] Hoffman Estates, Ill.-based Omron also previewed its new Omron Connect App which syncs with Omron connected devices so consumers can store, track and share heart health data with their doctors for better treatment and better outcomes.

The Omron HeartGuide, the first-ever wearable oscillometric wrist blood pressure monitor, comes in the form of a wristwatch with an inflatable cuff built into the watch band. The HeartGuide uses oscillometric measurement – the inflation of a cuff to measure systolic and diastolic pressure – which is still the only FDA-recognized standard for accurate, automated blood pressure measurement at home.

Omron has made significant advancements in design and comfort over the wrist wearable prototype previewed last year, the company noted. Omron has filed more than 50 new technology patents on the components developed for the HeartGuide, including miniaturization of blood pressure pumps, valves and chips that has never been achieved previously. Some of the pumps and valves in the device are no larger than a grain of rice.

Omron engineers used a flexible synthetic material five times stronger than steel to create the HeartGuide's watch band. This rare material, which is used in the airbags of NASA's Mars Lander, is strong yet flexible, allowing the band to inflate to take a reading while withstanding air pressure and maintaining its shape to ensure accurate measurement. The HeartGuide will mark the first time this material is used in a commercial health device.

"The wearable HeartGuide tracks sleep quality, and can be programmed to take a blood pressure reading while you sleep. Heart attack risk is higher in the last phase of sleep and in the morning. Checking blood pressure during sleep is an important option for hypertensive patients and an advancement in our pursuit of Going for Zero," Kellogg said.

The Omron HeartGuide will be submitted for FDA review later this year and will be clinically validated before it arrives for retail purchase.

The Omron Blood Pressure Monitor + EKG is the first blood pressure monitor in the U.S. for use at home that can also simultaneously take an EKG (electrocardiogram) reading, addressing a previously unmet need. According to the CDC, six million Americans have atrial fibrillation (AFib). Their stroke risk is five times higher. The Omron Blood Pressure Monitor + EKG has the unprecedented ability to monitor two critical risk factors for stroke.

"Previously, heart arrhythmia and blood pressure could not be easily measured together, outside of a doctor's office or hospital," Kellogg said. "The Omron Blood Pressure Monitor + EKG allows people who have AFib, and are at a higher risk of stroke, to gain stronger insights into their condition and more control over the risks that come with it. Now, those with AFib can gain a more complete picture of their heart health from a single device. And they can do it anytime, at home."

Omron developed this heart health technology with AliveCor, the market leader in FDA-cleared EKG technology. The Omron Blood Pressure Monitor + EKG will be submitted to the FDA later this year and will be clinically validated before it is available for retail purchase.

Along with these innovative new devices, Omron is previewing a new version of its smartphone app which syncs via Bluetooth with its connected heart health devices, including the HeartGuide, Omron Blood Pressure Monitor + EKG and the EVOLV. The Omron Connect App allows users to store, track and share their heart health data with their doctors for deeper heart health insights which can lead to better treatment, and better outcomes.

The new Omron Connect App can store a range of data collected by Omron connected devices, including blood pressure, EKG and heart rate. The app's user-friendly interface features an intuitive dashboard that conveniently charts and graphs data – viewable by day, week, month or year – making it easy for users to keep close watch on their heart health trends.

"The Omron Connect App encourages meaningful behavior change and more patient-doctor dialogue. With the app, users are encouraged to monitor their blood pressure regularly, to track their data over time and to share it with their doctors. More readings and more accurate data can be invaluable in making lifestyle and treatment changes and preventing cardiac events," said Kellogg.

The new Omron Connect App can be downloaded for free from the Apple iOS or Google Play stores in February 2018, in conjunction with Heart Health Month.

Omron Healthcare evolved its company mission to Going for Zero, the elimination of heart attack and stroke in December 2016. In the last year, the company has pursued its bold mission by developing new heart health technologies, launching a national education campaign, and forming partnerships with like-minded companies like AliveCor, combining their collective strengths to achieve new category breakthroughs.

"Hypertension means increased risk for heart attack and stroke. Millions of people don't know they have high blood pressure and are not aware of the risk they live with every day. The journey to better heart health begins with regular blood pressure monitoring," said Kellogg.
 

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Leading Pharma gets $40 million infusion for growth

BY David Salazar

Generic maker Leading Pharma recently completed a financing transaction for $40 million of growth capital. The growth capital, led by Signet Healthcare Partners and Crestline Investors, will be used to expand the Fairfield, N.J.-based company’s pipeline and pay off debt.

“This investment allows us to accelerate the development of our robust pipeline to build a more comprehensive product portfolio,” CEO and co-founder Ronald Gold said. “We are excited to partner with prudent investors who have experience in the pharmaceutical industry and believe in our business model as well as our ability to develop and market new generic drugs.”

Alongside the funding, Leading Pharma announced that Signet Healthcare Partners managing director Nikhil Puri and Crestline Investors managing director Chris Semple will join the board of Leading’s parent company.

Leading began as a company that exclusively outsourced its product development work, but following its acquisition of Excellium Pharmaceutical in 2014, the company said it has its own research and development capabilities, as well as a 53,000-sq.-ft. manufacturing facility for solid oral pharmaceuticals.

“I believe Leading Pharma has the necessary building blocks in place, and is well positioned to capitalize on the vast opportunity that the generic pharma sector presents,” Puri said “Signet is very pleased to be partnering with the company at this important juncture, and we look forward to close collaboration with the leadership team at Leading Pharma”.

Crestline Investors’ Semple said, “Under the leadership of industry veterans Ron Gold and Rasik Gondalia, Leading Pharma is well- positioned to capitalize on its development strategy as the company has built an attractive pipeline of diverse, difficult-to-formulate products. We look forward to continued growth at the company under Ron and Rasik, who have both successfully founded and exited generic pharmaceutical companies in prior ventures.”

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Lupin launches generic Ancobon

BY David Salazar

Lupin has added to its generics lineup with its version of Valeant Pharmaceuticals’ Ancobon (flucytosine) capsules. The drug is indicated to treat serious infections caused by candida and/or Cryptococcus.

The product will be available from Lupin in 250- and 500-mg dosage strengths. These dosage strengths had U.S. sales of roughly $48 million for the 12 months ended October 2017, according to IQVIA data.

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