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NUCLUES COCHLEAR IMPLANT telemedicine platform

Cochlear Americas

INDICATION FOR USE: Remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform. The remote programming feature is indicated for patients who have had six months of experience with their cochlear implant sound processor and are comfortable with the programming process

ADDRESSING UNMET NEED: 

  • 58,000 cochlear implants have been implanted in adults and 38,000 in children
  • Designed to produce useful hearing sensations for severe to profound hearing loss, by electrically stimulating nerves inside the inner ear
  • Often require regular programming visits with an audiologist
  • First telehealth option to program cochlear implants remotely

REGULATORY PATHWAY: PMA suppplement

  • Product Code : MCM

EFFECTIVENESS AND SAFETY:

  • Clinical study, n=39, aged 12 or older, with cochlear implant for at least one year
  • One in-person programming session and two remote programming sessions
  • Endpoint:  Speech perception tests showed no significant difference between in-person and remote programming
  • Endpoint: Patients’ self-assessment of hearing speech in presence of other sounds,  sense direction, distance and motion of sound
  • Endpoint: Cybersecurity measures for remote interaction

REIMBURSEMENT PATHWAY:

  • Telehealth as a service option in healthcare systems today- hospital networks, CMS

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RxSIGHT LIGHT ADJUSTABLE LENS AND LIGHT DELIVERY DEVICE

RxSight

INDICATION FOR USE:   Reduction residual astigmatism to improve uncorrected visual acuity after removal of the cataractous natural lens by phacoemulsification and implantation of the intraocular lens in the capsular bag, in adult patients

  • With pre-existing corneal astigmatism of  ≥ 0.75 diopters
  • Without pre-existing macular disease

The system also reduces the likelihood of clinically significant residual spherical refractive errors

ADDRESSING UNMET NEED:

  • Refractive errors  common following cataract surgery; corrected with glasses, contact lenses or refractive surgery
  • First system to make small adjustments to artificial lens’ power after cataract surgery to improve visual acuity without glasses

REGULATORY PATHWAY: PMA

  • Product Code: PZK

DESCRIPTION: 

  • The RxSight Intraocular lens (IOL)  made of unique material that reacts to UV light delivered by Light Delivery Device, 17-21 days after surgery
  • Three or four light treatments over a period of 1-2 weeks

EFFECTIVENESS AND SAFETY:

  • Randomized clinical study, n=600, Light Adjustable Lens vs. commercially available monofocal lens
  • Endpoint: Improvement of about one additional line down the vision chart, for distance vision without glasses vs. conventional IOL
  • Endpoint: Reduction in astigmatism in 75% patients

IMPACT tumor profiling test 

Memorial Sloan Kettering Cancer Center

INDICATION FOR USE: Qualitative in vitro diagnostic test that uses targeted next  generation sequencing of formalin-fixed paraffin-embedded tumor tissue matched with  normal specimens from patients with solid malignant neoplasms to detect tumor gene  alterations in a broad multi gene panel. The test is intended to provide information on somatic mutations (point mutations and small insertions and deletions) and microsatellite instability for use by qualified health care professionals in accordance with professional guidelines, and is not conclusive or prescriptive for labeled use of any specific therapeutic product. MSK-IMPACT is a single-site assay performed at Memorial Sloan Kettering Cancer Center

ADDRESSING UNMET NEED:

  • NGS technologies can examine hundreds, if not millions, of DNA variants at a time
  • By identifying what genetic mutations are present in tumor, test results can provide useful insight for best treatment
  • Established Class II regulatory pathway for review of other NGS-based tumor profiling tests

REGULATORY PATHWAY: De Novo request

  • Accreditation of the New York State Department of Health (NYSDOH) as an FDA third-party reviewer of in vitro diagnostics, including tests similar to IMPACT
  • NGS-based tumor profiling tests by NYSDOH do not need 510(k) clearance

GENERIC DEVICE TYPE:  Next generation sequencing (NGS) based tumor profiling test

  • Qualitative in vitro diagnostic test intended for NGS analysis of tissue specimens from malignant solid neoplasms to detect somatic mutations in a broad panel of targeted genes to aid in the management of previously diagnosed cancer patients by qualified health care professionals

PERFORMANCE:

  • High accuracy: > 99%  and capable of detecting a mutation at a frequency of approximately 5 %  (range of 2-5%)
  • Detection of certain molecular changes (microsatellite instability): concordant >92% across multiple cancer types in 175 cases vs. traditional detection methods

CLASSIFICATION ORDER


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JULUCA (dolutegravir and rilpivirine) tablets

GlaxoSmithKline (ViiV)

INDICATION:  Treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions  associated with resistance to the individual components of JULUCA

ADDRESSING UNMET NEED:

  • Estimated 1.1 million people in US living with HIV
  • Limiting number of drugs in HIV treatment regimen can help reduce toxicity

REGULATORY PATHWAY: NDA

MECHANISM OF ACTION:  Fixed-dose combination of the HIV-1 antiretroviral agents, dolutegravir and rilpivirine

EFFICACY:

  • 2 open-label, 148-week, randomized, multicenter, parallelgroup, non-inferiority trials, n=1,024 adult HIV–1-infected subjects; randomized 1:1 to continue current
    antiretroviral regimen or switched to JULUCA
  • Endpoint: HIV-1 RNA <50 copies/mL – Similar (95%)

SAFETY:

  • Most common side effects: Diarrhea and headache
  • Serious side effects: Skin rash and allergic reactions, liver problems, depression or mood changes

LABEL


Image result for hemlibra logoHEMLIBRA (emicizumab-kxwh) injection

Genentech, Inc.

INDICATION: Routine prophylaxis to prevent or reduce the frequency of bleeding
episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors

ADDRESSING UNMET NEED:

  • New option for reducing the frequency or preventing bleeding episodes
  • Important part of disease management for patients with hemophilia

REGULATORY PATHWAY: BLA

  • Priority Review, Breakthrough Therapy designation, Orphan Drug designation

MECHANISM OF ACTION:  Bridges activated factor IX and factor X to restore the function of missing activated factor VIII that is needed for effective hemostasis

EFFICACY:

  • An adult and adolescent trial  and a pediatric trial (HAVEN 2)
  • Randomized, multicenter, open-label, n= 109 adult and adolescent males with hemophilia, emicizumab-kxwh prophylaxis s. no prophylaxis
  • Endpoint: Annualized bleeding rate (ABR) 2.9 (95% CI; 1.7, 5.0) vs. 23.3 (95% CI: 12.3, 43.9), p<0.0001
  • Improvements in patient-reported hemophilia-related symptoms and physical functioning with prophylaxis
  • Single-arm, multicenter, open-label, n=23 pediatric males
  • ABR for treated bleeds was 0.2 (95% CI: 0.1, 0.6). ABR for all bleeds was 2.9 (95% CI: 1.8, 4.9)

SAFETY

  • Most common adverse reactions:  Injection site reactions, headache, and arthralgia
  • Cases of thrombotic microangiopathy and thrombotic events
  • Boxed warning: Thrombotic microangiopathy and thrombotic events

LABEL


Image Credits:Cochlear Americas, RxSight, Memorial Sloan Kettering Cancer Center, GSK, Genentech

 

 

 

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