Cigna (CI -0.5%) will offer Medicare
Advantage (MA) plans for the first time in the Denver and Boulder areas
of Colorado effective January 1, 2020. Medicare-eligible customers can
sign up beginning tomorrow, October 15, through December 7.
https://seekingalpha.com/news/3505563-cigna-expands-ma-footprint-colorado
Monday, October 14, 2019
Humana to continue Medicare presence in Florida
Humana (HUM -0.6%) announces that
it has been selected as one of five providers of Medicare coverage in
Florida beginning on January 1, 2020. It has provided this coverage in
the state for more than 30 years.
https://seekingalpha.com/news/3505565-humana-continue-medicare-presence-florida
https://seekingalpha.com/news/3505565-humana-continue-medicare-presence-florida
SmileDirectClub down 10% on potential headwinds in California
IPO flop SmileDirectClub (SDC -9.7%) continues its downward march, albeit on below-average volume. Shares have cratered almost 60% from the $23 IPO price.
The latest bad news is from California where Governor Gavin Newsom just signed Assembly Bill AB1519
which includes a mandatory bone imaging requirement (an X-ray) for
orthodontic patients, a standard that, it says, is a “thinly veiled
attempt” to protect traditional dentistry.
The company adds that the bill does not preclude
its continued operations in the state, but it does create “unnecessary
hurdles and costs” for patients.
In his signing statement, Mr. Newsom stated that
he expects all stakeholders to work together to find a better way to
create teledentistry policy. The bill will not go into effect until
stakeholders have the opportunity to submit public comments and debate
the merits of any proposed rules with clinical data.
The first step in the company’s current treatment
model is a 3D image of the customer’s teeth that is offered at no charge
in one of its retail stores or an impression kit ordered online that is
sent directly to the customer. At present, radiographic imaging is not
part of the process.
Competitor Align Technology (ALGN +2.8%)
is up on below-average volume. Its treatment model involves laser
imaging via its iTero intraoral scanners and dental x-rays (at the
dentist’s election).
https://seekingalpha.com/news/3505544-smiledirectclub-10-percent-potential-headwinds-californiaReNeuron shares clinical data on stem cell vision loss therapy
ReNeuron has presented detailed data from a phase 1/2a clinical trial
of its stem cell treatment for retinitis pigmentosa. Shares in ReNeuron
fell more than one-third after the release of top-line data at the
start of the month, but the biotech argued the detailed results are
positive for its prospects.
The phase 2a portion of the study enrolled 10 patients with the genetic vision loss disorder retinitis pigmentosa. Each received 1 million cells isolated from fetal retinas in one of their subretinal spaces. The trial was designed to assess the theory that the human retinal progenitor cells can slow, stop or reverse vision deterioration by comparing each patient’s treated and untreated eyes.
Data presented in April showed the vision in the treated eyes of the first three patients improved by more than 20 letters from baseline on a visual acuity scale. However, the results from the next five patients were less impressive, dragging the average two-month improvement from baseline down to 5.4 letters.
Pravin Dugel, a consultant to ReNeuron and clinical ophthalmology professor, provided more details (PDF) on what changed between the first and second updates at an event in San Francisco over the weekend.
Dugel highlighted the performance of two subjects who experienced events related to the surgical procedure or patient selection. The events led to vision loss. After 90 days, one of those patients had suffered a more than 40-letter deterioration in their treated eye. The other patient had experienced a more than 10-letter decline.
Data on the two subjects partly explain why the results presented this month were worse than the data shared on the first three patients in April. However, the other three recently treated patients who did not suffer adverse events only experienced relatively small improvements in their vision.
When the two patients who suffered adverse events are included in the analysis, the untreated eyes of the patients improved by more than the treated eyes at the 90-day cutoff. After removing those two patients, the average control-adjusted improvement in the treated eyes is 9.5 letters.
Dugel concluded his presentation by saying the phase 1/2a results will “provide a better understanding of optimal patient selection and surgical procedure standardization for future study design.” ReNeuron now plans to talk to its advisers and regulatory agencies about the design of its next retinitis pigmentosa clinical trial.
https://www.fiercebiotech.com/biotech/reneuron-shares-clinical-data-stem-cell-vision-loss-therapy
The phase 2a portion of the study enrolled 10 patients with the genetic vision loss disorder retinitis pigmentosa. Each received 1 million cells isolated from fetal retinas in one of their subretinal spaces. The trial was designed to assess the theory that the human retinal progenitor cells can slow, stop or reverse vision deterioration by comparing each patient’s treated and untreated eyes.
Data presented in April showed the vision in the treated eyes of the first three patients improved by more than 20 letters from baseline on a visual acuity scale. However, the results from the next five patients were less impressive, dragging the average two-month improvement from baseline down to 5.4 letters.
Dugel highlighted the performance of two subjects who experienced events related to the surgical procedure or patient selection. The events led to vision loss. After 90 days, one of those patients had suffered a more than 40-letter deterioration in their treated eye. The other patient had experienced a more than 10-letter decline.
Data on the two subjects partly explain why the results presented this month were worse than the data shared on the first three patients in April. However, the other three recently treated patients who did not suffer adverse events only experienced relatively small improvements in their vision.
When the two patients who suffered adverse events are included in the analysis, the untreated eyes of the patients improved by more than the treated eyes at the 90-day cutoff. After removing those two patients, the average control-adjusted improvement in the treated eyes is 9.5 letters.
Dugel concluded his presentation by saying the phase 1/2a results will “provide a better understanding of optimal patient selection and surgical procedure standardization for future study design.” ReNeuron now plans to talk to its advisers and regulatory agencies about the design of its next retinitis pigmentosa clinical trial.
https://www.fiercebiotech.com/biotech/reneuron-shares-clinical-data-stem-cell-vision-loss-therapy
Bayer to back 11 international startups in various digital health enterprises
Bayer has signed onto sprawling new collaborations with 11
digital health startups spanning areas such as oncology, ophthalmology,
pulmonology, radiology, digital therapeutics and cardiovascular health.
Formerly known as its Grants4Apps partnership program, the
German pharma has consolidated the group’s digital health initiatives
under the name G4A—pledging financial funding and research assistance.
The 11 participants were chosen out of over 750 applications from 65
countries, the company said.
The program also paves the way for longer-term
collaborations, including commercial development support to bring the
digital health products to market, said Zsuzsanna Varga, head of Bayer’s
G4A program, which is divided into two different pathways.
The “Growth Track” grants early-stage startups €75,000
($82,700 U.S.) for co-creating products, plus co-working space and
mentoring at Bayer’s pharmaceuticals division headquarters in Berlin.
Meanwhile, the “Advance Track” includes startups looking to co-create
and execute commercial deals and includes incremental milestone-based
payments.
The Growth Track includes the U.K.’s Okko Health,
developer of personalized smartphone software for remote monitoring of
visual health. Wellthy Therapeutics, based in India, is working on
behavioral interventions focused on chronic diseases. Litesprite, in the
U.S., creates mobile games to help users manage stress, anxiety and
depression.
Germany’s Visotec is building a handheld, at-home optical
coherence tomography scanner, while BioLum Sciences in the U.S. is
developing a low-cost, point-of-care device to analyze airway
inflammation. Upside Health in New York has made an app for chronic pain
management, employing cognitive behavioral therapy and other resources.
On the Advance Track, the startups include Prevencio Med, a
U.S.-based developer of blood tests and algorithms to predict a
person’s risk of heart disease; Blackford Analysis in the U.K., with its
marketplace of medical image analysis apps and AI algorithms; Canada’s
NeuroTracker, makers of a cognitive training program; Carepay, a
Kenya-based mobile health payment platform; and RelianceHMO, a health
insurance company using data science and telemedicine in Nigeria.
Additionally, Bayer recently spun its artificial intelligence imaging collaboration with the U.K.’s Sensyne Health into a full-fledged LifeHub project,
joining its innovation centers in Lyon, France, Berlin, Boston,
California, Singapore and Tokyo and Osaka, each centered on its own area
of expertise.https://www.fiercebiotech.com/medtech/bayer-to-back-11-startups-various-digital-health-enterprises
J&J Vision nets FDA approval for wavefront-guided PRK laser eye surgery
Johnson & Johnson Vision has secured FDA approval for a
new laser eye surgery indication for its iDesign Refractive Studio
system.
In addition, the company unveiled plans for the U.S.
rollout of a preloaded, disposable delivery system for its Tecnis
intraocular lenses for cataract patients. The announcements were made at
the annual meeting of the American Academy of Ophthalmology in San
Francisco.
The new indication covers wavefront-guided photorefractive
keratectomy, or PRK eye surgery, as an alternative to LASIK for the
treatment of nearsightedness. J&J Vision said it plans to make the
upgrade available through a software update in the first quarter of
2020. The iDesign system previously received approvals for myopia and
hyperopia, both with or without astigmatism, as well as monovision LASIK
procedures.
Wavefront-guided PRK and LASIK procedures allow for more personalized corrections during refractive surgery, according to the AAO.
In new clinical data presented at the meeting, J&J Vision said that
99% of patients achieved 20/16 or better vision at six months following
the procedure.
Meanwhile, the company said
its FDA-approved Tecnis Simplicity lens delivery system is now
available in the U.S. The preloaded and disposable device is designed to
prevent loading errors and protect the one-piece intraocular lens
against contamination, according to J&J Vision.
Additionally, J&J Vision debuted the CHiME
inventory management system for ophthalmology practices. The program and
accompanying supply cabinet aims to automate product processing and
ordering while tracking expiration dates. The company said it plans to
pilot the system at several U.S. practices over the next few months.
PolarityTE up on positive SkinTE data
Thinly traded nano cap PolarityTE (NASDAQ:PTE) is up 8% premarket on light volume in reaction to positive results
from an open-label single-arm pilot study evaluating SkinTE for closing
venous stasis leg ulcers (VLUs) that have not responded to convention
treatments. The data were presented at the Symposium on Advanced Wound
Care Fall Meeting in Las Vegas.
10 patients with VLUs that remained open after at
least one month of conventional treatments participated. After receiving
SkinTE, an autologous, homologous human cellular and tissue-based
product, 80% of the VLUs closed within 12 weeks. 100% of the VLUs showed
graft take and initial signs of closure.
A 100-subject Phase 1 trial is in process with an estimated completion date in September 2020.
https://seekingalpha.com/news/3505477-polarityte-8-percent-premarket-positive-skinte-data
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