The Pulse of Nikao.

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Happy Easter!

WESTON, Apr. 4, 2020 — The biggest joy of all is joining hands together and commemorating the resurrection of the Son of God. I wish you a memorable and blessed Easter day!!

Nikao, a leader in product design, manufacturing, and quick-turn printed circuit board design & manufacturing.  Our commitment to Quality and Our Client’s Success is what sets us apart.  Nikao is FDA Registered, CE Registered, MDD Certified, ISO 13485:2016 Certified, and cGMP Certified, offering further assurance that we deliver only the highest quality products and solutions to all our clients.  Nikao is manufacturing technologies that are touching and improving the quality of life of hundreds of thousands of patients worldwide.

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Nikao Exhibiting @ AmCon Show 2021

WESTON, April. 01, 2021 | NIKAO is proud to announce we were named one of the top manufacturing companies in the USA.  We are also excited to announce that we will be exhibiting for the fourth straight year at the AmCon Show Orlando April 27 – April 28, 2021 at the Orange County Convention Center.  Please come join us at Booth 312 – Nikao is committed to providing the highest performing and quality  products in the industry.  Our commitment to our Quality Management System and Client’s Success is what sets us apart.  Nikao is FDA Registered, CE Registered, MDD Certified, ISO 13485:2016 Certified, and cGMP Certified, offering further assurance that we deliver only the highest quality products and solutions to all our clients.  Nikao is manufacturing technologies that are touching and improving the quality of life of hundreds of thousands of patients worldwide.

 

 

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Nikao & ReIntraocular

WESTON, Feb. 19, 2020 — NIKAO is proud to announce we have signed an agreement with ReIntraocular, Inc. to become their exclusive manufacturing and distribution partner. ReIntraocular is a medical device company that developed the Honan Balloon that permits surgeons to effectively lower intraocular pressure by a known low external pressure prior to intraocular surgery.

Application of the Honan Intraocular Pressure Reducer after retrobulbar or peribulbar injection of anesthetic agent serves several purposes. It aids in diffusion of the anesthetic agent to paralyze the extraocular muscles. A separate lid block is not needed. Highly desirable is the resulting soft safe eye for cataract surgery and implantation of an intraocular lens. Ocular compression reduces the intraocular pressure and in addition reduces the volume of the orbital contents. This latter desirable result decreases the normal tissue pressure on the globe itself. Thus there is safety in decreased tendency for expulsion of the ocular contents when the eye is open during intraocular surgery.

If You Can Dream it, We Can Create it!

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Our Christmas Tree

WESTON, Dec. 1, 2020 — OUR CHRISTMAS TREE.  We hope you had a wonderful and blessed Thanksgiving! We’ve been quite busy around here working on new projects, and with our great clients.  Today, we wanted to share our Christmas Tree with you!  We want to thank Fanny, Yolimar, and the entire team for our Beautiful tree this year!

Nikao, a leader in product design, manufacturing, and quick-turn printed circuit board design & manufacturing.  Our commitment to Quality and Our Client’s Success is what sets us apart.  Nikao is FDA Registered, CE Registered, MDD Certified, ISO 13485:2016 Certified, and cGMP Certified, offering further assurance that we deliver only the highest quality products and solutions to all our clients.  Nikao is manufacturing technologies that are touching and improving the quality of life of hundreds of thousands of patients worldwide.

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Nikao Purchases New PCB Equipment

WESTON, Oct. 13, 2020 — Nikao, a leader in product design, manufacturing, and quick-turn printed circuit board design & manufacturing, announced today the investment in new pick and place and inspection equipment, confirming its commitment to provide quality products and on-time delivery.  Nikao is committed to providing the highest performing and quality Printed Circuit Boards (PCB’s) in the industry.  Nikao provides the highest quality PCB’s at the most competitive prices in the industry.  Our commitment to our Quality Management System and Client’s Success is what sets us apart.  Nikao is FDA Registered, CE Registered, MDD Certified, ISO 13485:2016 Certified, and cGMP Certified, offering further assurance that we deliver only the highest quality products and solutions to all our clients.  Nikao is manufacturing technologies that are touching and improving the quality of life of hundreds of thousands of patients worldwide.

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Nikao & UHT

WESTON, Sept. 10, 2020 — NIKAO is proud to announce we have signed an agreement with UHT to develop their new product. UHT is a medical device company that specializes in micro current technology. Their Hemorrhoid management system allows physicians to treat internal and mixed hemorrhoids with a quick and easy procedure.

The UHM System provides doctors with a monopolar low voltage instrument that delivers a current directly to the affected area. The electrical charge causes the hemorrhoid to shrink within 7 to 10 days with some patients getting relief instantly from the system.

The patient requires no anesthesia or preparation. The application process affects no nerve endings during the treatment, so the patient feels no pain. The procedure takes about 30 minutes from start to finish.

One of the primary reasons the UHT system is a better option for the treatment of hemorrhoids is pain control. The UHM System is a painless solution because it works in the area above the dentate line. Other considerations include:

UHT treats Grade I, II, III and IV internal and mixed hemorrhoids
UHT treatment require no hospitalization. The procedure is done in the office.
UHT is FDA-approved and accepted by most insurers including Medicare
Patients require no recovery period. They are able to return to normal activity immediately after the procedure.

If You Can Dream it, We Can Create it!

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Nikao & DermaSensor

WESTON, June. 04, 2020 — NIKAO is proud to announce that our partner DermaSensor has raised $11.5 million in a Series A Preferred Stock financing.

On the road to bringing its first device to market, DermaSensor, a Miami-based health-tech company designing tools to better equip primary care providers for skin cancer checks, today announced it has raised $11.5 million in a Series A Preferred Stock financing.

The round was led by Dr. Maurice R. Ferré, David Matlin, Chris Dewey and SternAegis Ventures. Ceros Financial Services acted as exclusive placement agent for a significant portion of this Series A financing. The round also included the Miami Angels. This brings the company’s total funding to date to $17 million.

With about 20% of Americans diagnosed with skin cancer, DermaSensor developed an affordable product designed to help the more than 200,000 primary care providers in evaluating patients with suspicious moles. The majority of Americans have never been checked for skin cancer.

“We expect our device, with its ability to assess a lesion in under 30 seconds using objective spectroscopy and machine learning technology, to become a standard tool of the trade in primary care,” said CEO Cody Simmons in a statement. “99% of melanoma is curable if detected early, and we want to equip primary care providers since they’re well positioned to play an important role in early detection.”

The new funding round will be used for finishing clinical submission work for the FDA, the company’s upcoming commercial efforts abroad and product development work, Simmons said in an interview with Refresh Miami.

“DermaSensor is poised for strong adoption in the market with its novel, patented technology and demonstrated, industry-leading performance,” said Ferré, DermaSensor’s chairman and a lead investor. “We’re pleased to support the next step of launching this device commercially to benefit physicians and their patients.”

A multi-center, prospective clinical study was recently published showing that DermaSensor’s automated spectroscopy and machine learning technology achieved a sensitivity of 100 percent for detecting melanoma and 94 percent for detecting non-melanoma skin cancer, Simmons said. The results are from an independent test set of 126 skin cancers and are separate from the company’s pivotal study for the FDA.

DermaSensor is preparing to submit to FDA for pre-market clearance and is near completion for the CE Mark. While the COVID crisis has slowed down some clinical studies, the company expects to pilot its flagship device commercially this summer outside of the United States. As medical devices usually are, it’s been a long road to commercialization, and the company has has spent the last several years miniaturizing its spectroscopy technology into a hand-held device. In 2011, the technology was the size of a 30-p0und suitcase.

How the product works: A physician gently touches the non-invasive device tip to a selected mole, and a spectral sensor records how dozens of wavelengths of light reflect off cells beneath the surface of the skin. A proprietary algorithm instantly analyzes the reflected photons to provide a simple “Higher Risk” or “Lower Risk” output that supports a physician’s referral decision, converging the powers of machine learning and clinical evaluation.

DermaSensor was co-founded by Ferré, a medical device industry veteran who sold MAKO Surgical and is now running INSIGHTEC heavily backed by Koch Disruptive Technologies. Simmons worked in Silicon Valley at Genentech and a couple of health-tech startups before joining DermaSensor in 2016 as CEO.

Today, DermaSensor is a team of 11, and Simmons expects to hire a couple more people for the upcoming overseas launch. DermaSensor has a number of Miami ties. Its product development and manufacturing work is being done by Nikao, a Weston company Simmons was connected to through eMerge Americas, and it’s a client of the Miami-based law firm Private Advising Group. Also, Simmons was a finalist for the Rise of the Rest competition last May.

“After a decade-long clinical and product development road to now finally soon launching a product commercially and getting through the necessary hurdles with regulators, we are very excited to get this first ever cancer device developed specifically for primary care providers launched into the world,” said Simmons. “It’s all about improving access to effective skin cancer checks and we think a quick, easy to use, low cost tool with high performance like ours can be a game changer for that.”

DermaSensor was founded in 2009 by healthcare investor and serial entrepreneur Dr. Maurice Ferré, who was previously the CEO of MAKO Surgical, which sold to Stryker for $1.65 billion. Ferré, son of the former Miami mayor, is also chairman and CEO of Insightec, a brain health company founded in Israel; co-founder of Miami-based Fastrack Institute; and on the board of Endeavor Miami, an organization that supports high-impact entrepreneurship.

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Specializing in FDA Regulatory Submissions & Strategy

WESTON, Mar. 5, 2020 — NIKAO is proud to announce that we are expanding upon our industry leading services to provide assistance to foreign medical device companies attempting to market their products in the USA.

Our strategic planning includes developing a strategy and partnership with foreign medical device class I and II manufactures who are not able to market their products due to constraints and lack of knowledge about 510{k} processes. Our specialty is preparing, submitting and shepherding 510(k) Premarket Notifications through the U.S. Food & Drug Administration (FDA).

We cater to foreign small businesses that manufacture medical devices for the American market. Whether you have a brand new product that you are looking to commercialize or need regulatory assistance with a currently-marketed product, we can help with all aspects of FDA regulatory submissions and strategy.

You Make It. We Clear It…Your Company Grows.

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1880 n commerce pkwy weston fl 33326

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