One Drop launches blood glucose prediction, decision support features

One Drop this week launched blood glucose prediction and automated decision support features for its mobile app designed to help people manage their diabetes.

The company said that the new features will enable its mobile app to give blood glucose predictions up to 12 hours into the future and behavioral recommendations based on those forecasts.

Get the full story at our sister site, Drug Delivery Business News.

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J&J leads $35m round for sleep-focused neurotech dev Dreem

Johnson & Johnson‘s (NYSE:JNJ) Innovation JJDC investment arm this week led a $35 million funding round for sleep-focused neurotechnology company Dreem.

San Francisco-based Dreem is developing a number of devices focused on addressing sleep problems, including a headband designed to both monitor brain activity to track sleep accurately and use auditory stimulation to aid in promoting sleep.

Dreem said that with the funding round, which joins a previous round which raised $22 million for the company, it will look to expand its sleep technology into new global markets and increase its R&D funding for future studies and innovations.

“Understanding and improving sleep is one of the most important technological, scientific and societal undertakings of our time. If everyone in the world, of which 30% don’t sleep effectively today, were able to get better, more quality rest every night – we’d unleash opportunity like none other. Our productivity, creativity, humility as a global community could dramatically increase. Our mission at Dreem is to help the world make that happen. We want to become the accessible, universally effective solution for everyone on the planet suffering from a poor sleep quality. And, while this journey is challenging and complex, we have everything we need – incredibly talented people, years of research at our disposal, tenacity and passion, and now a powerful set of new investors – to accelerate our team’s vision of changing lives by helping the world get better, healthier and more effective sleep,” CEO Hugo Mercier said in a press release.

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Senseonics prices $130m public offering

On the heels of an FDA approval for its implantable continuous glucose monitoring tech, Senseonics‘ (NYSE:SENS) today priced a $130 million underwritten public offering of common stock.

The offering, which is slated to close on June 28, also includes a 30-day option for underwriters to buy additional shares of common stock worth up to $19.5 million.

Get the full story at our sister site, Drug Delivery Business News.

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New clinical study personnel: How to manage the changes at your site

Melissa Wollerman, Clinical Research Associate, IMARC

As many of us monitors are aware, there is high turnover in the research industry and clinical sites aren’t exempt from this. Quite often, we are likely to receive an e-mail with very little information regarding the current study coordinator or other study personnel leaving a clinical site. We may possibly receive a sentence that consists of who will be taking their place, or perhaps no notification at all.

How do you go about handling the notification, or lack of notification?

1. Stay calm. If a monitor has received many of these e-mails before, they know that this can be frustrating; having to train yet another coordinator or investigator that may not be with the site for very long. It’s important to keep your composure and respond to that e-mail expressing gratitude for the notification and for their time and efforts on the study.
2. Keep in contact. A great way to avoid silence from the site is to often keep in contact with them. A consistent relationship can go a long way, and simply having a personable attitude will make the transition a lot smoother.
3. Understand the site. Perhaps the site is one that rotates fellows every 6-7 months or has an intern that may only be on the study for the summer. Get to know the site at the first visit so that you can be prepared for these changes.
4. Inform applicable personnel. The notification from the site may have only been sent to the monitor and no other team members. It’s important to also ensure that all appropriate study team personnel are aware of the change. A simple e-mail to the Sponsor and other members of the study team will ensure that everyone is notified and up-to-date with the personnel changes and can fast-track the training process.
5. Properly train the new study member. It can be frustrating for the new study personnel who may be walking into a study that is unorganized with little hand-off training by the previous personnel at the site.   Also, being brand new to the study and not knowing the process and expectations can be challenging. Ensure that enough time is devoted to training the new member so that they feel comfortable with the study, possibly resulting in a stronger relationship with the monitor.

When you receive that e-mail from the site notifying you that there will be a change in contact, glance over the points above and think about how you can efficiently conduct the onboarding process to ensure you are prepared for this change and future changes.

Have you experienced high turnover at your sites? How did you proceed with the information you were given regarding the new study personnel? How can you make this process better and more efficient?

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Closed-loop insulin delivery systems shine at annual diabetes meeting

As device-makers, healthcare practitioners and people with diabetes convened at this year’s annual meeting of the American Diabetes Association, one major theme emerged: the industry is catching on to the potential of closed-loop insulin delivery systems.

Major medical technology companies, including Medtronic and Insulet, touted data at this year’s meeting demonstrating the benefits of their systems that connect glucose monitoring data and insulin dosing. Patient advocacy groups, like the JDRF, have called on the industry to fund and develop automated insulin delivery systems – echoing the calls of a community of people with diabetes that have already been doing this themselves.

Get the full story at our sister site, Drug Delivery Business News.

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General Electric to spin out GE Healthcare

General Electric (NYSE:GE) said today that it plans to spin out its GE Healthcare subsidiary as a stand-alone, publicly traded entity to focus on its aviation, power and renewable energy businesses.

The Boston-based industrial conglomerate also said it’s planning an “orderly separation” from its 62.5% stake in BHGE oil and gas servicing and equipment unit over the next two to three years.

Little Chalfont, U.K.-based GE Healthcare has long been a bright spot for its parent, consistently posting sales and profit gains despite overall declines at GE. In April division agreed to sell its value-based healthcare division to Veritas Capital for $1.05 billion in cash; that deal is expected to close during the third quarter.

Today General Electric CEO John Flannery – formerly head of the healthcare unit – said GE Healthcare chief Kieran Murphy will stay on to the lead the $19 billion company after its emancipation.

“GE Healthcare’s vision is to drive more individualized, precise and effective patient outcomes. As an independent global healthcare business, we will have greater flexibility to pursue future growth opportunities, react quickly to changes in the industry and invest in innovation. We will build on strong customer demand for integrated precision health solutions and great technology with digital and analytics capabilities as we enter our next chapter,” Murphy said in prepared remarks.

“GE Healthcare is an industry leader with financial strength, global scale and cutting-edge technology. Our talented healthcare team will continue delivering precision health solutions, building on our heritage of technology innovation that delivers patient outcomes,” Flannery added.

The plan calls for the sale of a 20% stake in the business, with the balance to be transferred to GE shareholders in a tax-free distribution, the company said. The spinout is slated to be complete over the next year to 18 months, with the exact structure, sequence and timing to be determined.

GE also said it’s board elected former Danaher (NYSE:DHR) CEO Larry Culp to succeed Jack Brennan, effective today, naming Culp chairman of its management development & compensation committee.

“Today marks an important milestone in GE’s history. We are aggressively driving forward as an aviation, power and renewable energy company – three highly complementary businesses poised for future growth. We will continue to improve our operations and balance sheet as we make GE simpler and stronger,” Flannery said.

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Orthofix pivots to spine, extremities

Orthofix (NSDQ:OFIX) said yesterday that it’s planning a pivot to the spine and extremities market beginning next year, folding its biostim and biologics businesses back into the spine segment five years after it split them out in the first place.

In July 2013 Lewisville, Texas-based Orthofix split the spine segment into biostim and spine fixation divisions, promoting Brad Niemann from commercial operations SVP to lead the biostim biz. Later that month the company restated its financial results covering more than two years, after discovering improperly recognized revenues.

Today the company said it would maintain fiscal reporting with four divisions until the transition is complete, expected at the beginning of 2019, and named Niemann president of the spine division, which will encompass the biostim, spine fixation, biologics units plus the Spinal Kinetics business, acquired last month for $105 million. Spinal Kinetics developed the M6 cervical disc implant. Orthofix said Davide Bianchi will continue to lead the extremities business as president.

“In 2013, Orthofix segmented its business into four strategic business units to gain better strategic and management focus and drive needed performance improvements,” president & CEO Brad Mason said in prepared remarks. “This strategy has proved very successful over the last several years and resulted in each business performing well with solid leadership, execution and growth.

“Today we are announcing these organizational changes as part of an overall strategy to position the company for growth acceleration and to realize opportunities that can only be achieved by leveraging our full portfolio of spine solutions,” Mason said. “As we expand our product offerings and integrate new technologies, such as the M6 disc, we believe the time is right to further optimize our structure to better serve our surgeon customers through a two-pillar approach of a consolidated spine group and a focused extremities business. We are fortunate to have two extremely talented executives to lead these organizations.”

“I am excited to have the opportunity to lead the spine group and look forward to working more closely with the current management teams from all the spine product areas,” Niemann added. “This structure will foster better collaboration and alignment by bringing these teams together under one umbrella to help ensure we make the most of our many opportunities in the market.”

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