Silver Bullet Therapeutics Reports Results of OrthoFuzIon® Antimicrobial Bone Screw Testing Against the Top Six CDC Antibiotic Resistant “Superbugs”1

Posted On November 4, 2016 By OrthoSpineNews In Biologics /

November 03, 2016

SAN JOSE, Calif.–(BUSINESS WIRE)–Silver Bullet Therapeutics, Inc., a privately held medical device company that has developed an antimicrobial technology for implantable medical devices such as orthopedic bone screws, reported today the results of a study testing the “Time Kill” and “Adherence” effectiveness of its CE-marked OrthoFuzIon^® Antimicrobial Bone Screw against the Top Six CDC Antibiotic-Resistant “Superbugs.”¹ The study was performed by Emery Pharma, which is a certified, third party testing laboratory. The study consisted of testing a number of the OrthoFuzIon antimicrobial screws against traditional uncoated titanium screws as a control. The organisms tested in-house and by Emery Pharma form the Top Six antibiotic resistant “superbugs” that include: Carbapenem-resistant Enterobacteriaceae (CRE); Klebsiella pneumoniae; Methicillin-resistant Staphylococcus aureus (MRSA); ESBL-producing Enterobacteriaceae (extended-spectrum β-lactamases); Escherichia coli (E. coli); Vancomycin-resistant Enterococcus (VRE); Enterococcus faecium; Multidrug-resistant Pseudomonas aeruginosa; and Multidrug-resistant Acinetobacter baumannii.

“Our OrthoFuzIon coating creates a galvanic zone of bacterial inhibition surrounding the implanted screw within the body,” said founder, President and CEO Paul Chirico. “This is particularly important as the concern, costs and responsibility related to device-contaminations rise.”

“Medical device infections can be costly, cause increased morbidity and lead to device failure,” said Prity S. Vaidya, M.D., an infectious disease specialist. “These microbiology test results using the OrthoFuzIon device are very encouraging considering the type of organisms tested against.”

“Adherence” testing indicated the ability of an OrthoFuzIon device to penetrate bacterial biofilm. Biofilms are formed by many species of bacteria for cell adherence and protection. By creating biofilms, bacteria can form colonies almost anywhere, including in the human body and on implanted medical devices. Biofilms produced by bacteria render most currently available antibiotics ineffective by creating a “shield” through which antibiotics cannot penetrate. This test demonstrated that the OrthoFuzIon Antimicrobial Bone Screw was able to significantly disrupt the development of biofilm.

“We conduct antimicrobial testing on different devices and technologies,” said Ron Najafi, Ph.D., President and CEO of Emery Pharma Services. “We were most impressed by the ‘adherence’ results for the OrthoFuzIon device against the top six antibiotic resistant pathogens that are commonly implicated in hospital-acquired infections. The results of OrthoFuzlon preventing these pathogens from adhering to them were simply impressive.”

OrthoFuzIon is one of the first antimicrobial implantable medical devices designed specifically for orthopedics. The proprietary Silver Bullet coating applied to OrthoFuzIon causes a “galvanic” reaction wherein the silver component ionizes, creating a localized “cloud” of silver ions that surrounds the implanted device and that acts as a deterrent to bacterial colonization.

About Silver Bullet Therapeutics

Silver Bullet Therapeutics, Inc., a privately held company located in San Jose, Calif., has developed and patented antimicrobial coating processes as well as implants and medical devices to address surgical-site infections (SSIs) and hospital-acquired infections (HAIs). The company’s first commercial product, the OrthoFuzIon Bone Screw System, utilizes an advanced silver ion technology that allows for rapid and sustained ionization of the silver and creation of an antimicrobial zone around the screw to prevent microbial colonization of the implanted devices. OrthoFuzIon is a Trademark of Silver Bullet Therapeutics, Inc., and is currently approved for sale only in the European Union.

About Emery Pharma

Emery Pharma (http://emerypharma.com) is a full-service contract research laboratory, specializing in analytical, bioanalytical, microbiology, cell biology testing and medicinal chemistry support. Emery Pharma supports a wide range of companies from startups consisting of a single scientist, to large multinational and national laboratories. Emery Pharma operates as an extension of its clients’ R&D department. Emery Pharma engages top-level Ph.D. and M.S. scientists to streamline and optimize clients’ projects in Pharma, Biotech, Cleantech, Agrochem and many other industries.

¹ – http://www.cdc.gov/media/releases/2016/p0303-superbugs.html

Contacts

Silver Bullet Therapeutics, Inc.
Ronald Trahan, 508-359-4005, x108
rtrahan@ronaldtrahan.com

Special Protein in Zebrafish May Lead to Full Spinal Cord Repair

Posted On November 4, 2016 By OrthoSpineNews In Biologics, Neuro /

Nov 04, 2016 – By Rhenn Anthony Taguiam

Researchers have discovered that zebrafish — the two-buck wonders in pet stores — may actually hold the key to do full spinal cord repair. It seems the zebrafish is capable of healing a completely severed spinal cord with special proteins.

An injury of this kind in humans can be paralyzing and can even lead to fatal conditions.

Researchers from Duke University have discovered that zebrafish possess a special protein that allows them to heal their severed spine. According to Medical Xpress, the study, published in Science, could lead to developments in tissue repair in humans.

Duke University’s Kenneth Poss claimed this is one of “nature’s most remarkable feats of regeneration.” This is because its potential implications and usage in the world of medicine is astounding. There are currently very limited methods of tissue repair, and animals like zebrafish may hold the key.

A zebrafish’s severed spinal cord forms a literal “bridge” that connects the gap in the injury. Cells form and extend to distances 10 times their own length to heal themselves. By eight weeks, the animals may have already fully reversed their paralysis.

Poss and his team conducted “molecular fishing” to find out which genes are responsible for such activity. It appears the CTGF or the connective tissue growth factor increases while the supporting cells appear to repair the injury.

READ THE REST HERE

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Spine Implants Market in the US 2016-2020; New Report Launched

Posted On November 4, 2016 By OrthoSpineNews In Financial /

Bangalore, Karnataka — (SBWIRE) — 11/04/2016 — The spine implants help in correcting deformities of the spine and restoring the function of the spine. Some of the conditions that require the use of spine implants are spondylolisthesis, chronic degenerative disc diseases (DDDs), traumatic fracture, and other forms of spinal instability including scoliosis. These implants are mainly composed of titanium, stainless steel, polyether ether ketone (PEEK), carbon fiber, and other bio-absorbable materials.

Report forecast the spine implants market in the US to grow at a CAGR of 5.29% during the period 2016-2020.

The report covers the present scenario and the growth prospects of the spine implants market in the US for 2016-2020. To calculate the market size, the report considers the revenue generated from the sales generated from the sales of spine implants.

Spine Implants Market in the US 2016-2020, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market.

Key vendors
– Medtronic
– DeBuy Synthes
– Stryker
– NuVasive

Other prominent vendors
– AccelSPINE (CTL Medical Group)
– AESCULAP
– Alliance Spine
– Alphatec Spine
– Amedica Corporation
– Globus Medical
– K2M
– LDR
– Life Spine
– Orthofix International
– Paradigm Spine
– Precision Spine
– RTI Surgical
– Spine Surgical Innovations
– Spineology
– Titan Spine
– TranS1
– Wenzel Spine
– Zimmer Biomet
– Zyga Technology

Market driver
– Increasing prevalence of spinal disorders such as spinal stenosis
– For a full, detailed list, view our report

Market challenge
– Lack of product differentiation
– For a full, detailed list, view our report

Market trend
– Emerging motion preservation technology (non-fusion)
– For a full, detailed list, view our report

Key questions answered in this report
– What will the market size be in 2020 and what will the growth rate be?
– What are the key market trends?
– What is driving this market?
– What are the challenges to market growth?
– Who are the key vendors in this market space?
– What are the market opportunities and threats faced by the key vendors?
– What are the strengths and weaknesses of the key vendors?

Spanning over 80 pages “Spine Implants Market in the US 2016-2020” report covers Executive summary, Scope of the report, Market research methodology, Introduction, Market landscape, Market segmentation by product, Market segmentation by procedure, Market segmentation by end-user, Market drivers, Impact of drivers, Market challenges, Impact of drivers and challenges, Market trends, Vendor landscape, Key vendor analysis, Appendix.

For more information Visit at: http://www.drugpipeline.net/technavio/spine-implants-market-us-2016-2020

About DrugPipeline.net
DrugPipeline.net is a market research reports distribution platform which hosts research reports from all leading global market research firms related to pharma industry. It also assist decision makers locate the right market research solution from a single place.

ConforMIS Reports Third Quarter 2016 Financial Results

Posted On November 3, 2016 By OrthoSpineNews In Financial /

BEDFORD, Mass., Nov. 03, 2016 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are customized to fit each patient’s unique anatomy, announced today financial results for the third quarter ended September 30, 2016.

Q3 Summary:

Total revenue of $18.6 million, up 34% year-over-year on a reported basis and up 35% year-over-year on a constant currency basis.
Product revenue of $18.4 million, up 36% year-over-year on a reported basis and up 37% year-over-year on a constant currency basis
- U.S. product revenue increased 43% year-over-year
- Rest of World product revenue increased 14% year-over-year on a reported basis and 18% year-over-year on a constant currency basis

“We had a solid third quarter of 2016,” said Philipp Lang, MD, MBA, President and Chief Executive Officer of ConforMIS, Inc. “We saw double digit growth in our base business year-over-year with iTotal CR and our partial knee systems. The revenue growth for our newest product, iTotal PS, has been impressive. This innovative product approximately triples the addressable market for ConforMIS and is rapidly becoming our flagship product for new surgeon acquisition.”

Dr. Lang continued, “We have completed enrollment in our single timepoint study comparing iTotal CR to leading off-the-shelf implants in over 800 patients. The results to-date show that patients that received an iTotal CR implant were significantly faster at completing three functional tests of daily living, including walking, than patients with an off-the-shelf implant. We believe that this and other direct comparative studies will help us increase the utilization of our implants with current and new surgeons.”

Third Quarter 2016 Financial Results

	Three months ended September 30,				Increase/decrease
*($, in thousands)*		2016		2015	$ Change			% Change			% Change
								*(as reported)*			*(constant currency)*
United States	$	14,954	$	10,466	$	4,488			43	%		43	%
Rest of world		3,446		3,024		421			14	%		18	%
Product revenue		18,400		13,490		4,910			36	%		37	%
Royalty revenue		243		404		(161	)		-40	%		-40	%
Total revenue	$	18,643	$	13,894	$	4,749			34	%		35	%

Total revenue increased $4.7 million to $18.6 million, or 34% year-over-year on a reported basis and 35% year-over-year on a constant currency basis, as compared to the third quarter of 2015, which was affected by our product recall. Total revenue in the third quarter of 2016 included royalty revenue of $0.2 million as compared to $0.4 million in the third quarter of 2015.

Product revenue increased $4.9 million to $18.4 million, or 36% year-over-year on a reported basis and 37% year-over-year on a constant currency basis. U.S. product revenue increased $4.5 million to $15.0 million, or 43% year-over-year, and Rest of World product revenue increased $0.4 million to $3.4 million, or 14% year-over-year on a reported basis and 18% on a constant currency basis. Product revenue from sales of iTotal CR, iDuo and iUni increased $1.7 million to $14.4 million, or 13% year-over-year on a reported basis and 14% year-over-year on a constant currency basis. Product revenue from sales of iTotal PS increased $3.2 million to $4.0 million, or 401% year-over-year on a reported basis and 403% year-over-year on a constant currency basis.

Gross profit increased $3.2 million to $6.0 million, or 32% of revenue, which included $1.3 million in unused product, in the third quarter of 2016, compared to $2.8 million, or 20% of revenue, which included $0.8 million in unused product, in the third quarter of 2015. This increase in gross profit was driven primarily by higher product revenue in 2016 compared to 2015.

Total operating expenses decreased $0.1 million to $18.9 million, or 0.4% year-over-year. The decrease in expenses was driven primarily by lower sales and marketing costs and lower general and administrative costs, offset by slightly higher research and development costs compared to the third quarter of 2015.

Net loss was $12.8 million, or $0.31 per basic share, in the third quarter of 2016, compared to a net loss of $17.1 million, or $0.45 per basic share, for the same period last year. This decrease in net loss was driven primarily by higher product revenue in 2016 compared to 2015.

As of September 30, 2016, the Company’s cash and cash equivalents and short and long-term investments totaled $75.8 million, compared to $117.2 million as of December 31, 2015.

Note on Non-GAAP Financial Measures

In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company provides certain information regarding the Company’s financial results or projected financial results on a non-GAAP “constant currency basis.” This information estimates the impact of changes in foreign currency rates on the translation of the Company’s current or projected future period financial results as compared to the applicable comparable period. This impact is derived by taking the adjusted current or projected local currency results and translating them into U.S. Dollars based upon the foreign currency exchange rates for the applicable comparable period. It does not include any other effect of changes in foreign currency rates on the Company’s results or business. Non-GAAP information is not a substitute for, and is not superior to, information presented on a GAAP basis.

Conference Call

As previously announced, ConforMIS will conduct a conference call and webcast today at 4:30 PM Eastern Time. Management will discuss financial results and strategic matters. To participate in the conference call, please call 877-809-6331 (or 615-247-0224 for international) and use conference ID number 5481072 or listen to the webcast in the investor relations section of the company’s website at ir.conformis.com. The online archive of the webcast will be available on the company’s website for 30 days.

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 500 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com/.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements about our strategy, future operations, future financial position and results, market growth, total revenue and revenue mix by product and geography, operating trends, the potential impact and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates regarding the potential market opportunity for our current and future products, our expectations regarding our sales, expenses, and other results of operations, growth in our customer base, the impact of the CJR program, contracting trends, the impact of our voluntary recall on financial results and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

CONFORMIS, INC. AND SUBSIDIARIES
Consolidated Statements of Operations
(in thousands, except share and per share data)

			Three Months Ended September 30,						Nine Months Ended September 30,
				2016			2015			2016			2015

Revenue
	Product		$	18,400		$	13,490		$	57,486		$	43,953
	Royalty			243			404			740			3,863
Total revenue				18,643			13,894			58,226			47,816
Cost of revenue				12,645			11,132			39,564			32,371
	Gross profit			5,998			2,762			18,662			15,445

Operating expenses
	Sales and marketing			9,301			9,433			31,063			27,584
	Research and development			4,099			3,885			12,474			12,218
	General and administrative			5,503			5,656			17,285			16,790

		Total operating expenses		18,903			18,974			60,822			56,592
Loss from operations				(12,905	)		(16,212	)		(42,160	)		(41,147	)

Other income and expenses
	Interest income			127			24			409			92
	Interest expense			(4	)		(911	)		(104	)		(1,380	)
	Other income (expense)			34			–			34			208
		Total other expenses		157			(887	)		339			(1,080	)
Loss before income taxes				(12,748	)		(17,099	)		(41,821	)		(42,227	)
	Income tax provision			14			8			27			29

Net loss			$	(12,762	)	$	(17,107	)	$	(41,848	)	$	(42,256	)

Net loss per share – basic and diluted			$	(0.31	)	$	(0.45	)	$	(1.01	)	$	(2.69	)
Weighted average common shares outstanding – basic and diluted				41,682,244			37,933,069			41,332,958			15,688,686

CONFORMIS, INC. AND SUBSIDIARIES
Consolidated Balance Sheets
(in thousands, except share and per share data)

					September 30, 2016			December 31, 2015
					September 30, 2016			December 31, 2015
Assets					(unaudited)
	Current Assets
		Cash and cash equivalents			$	34,986		$	117,185
		Investments				38,337			–
		Accounts receivable, net				13,839			14,867
		Inventories				11,755			11,520
		Prepaid expenses and other current assets				2,242			2,451
			Total current assets			101,159			146,023
	Property and equipment, net					14,985			10,966
	Other Assets
		Restricted cash				300			600
		Investments				2,497			–
		Intangible assets, net				808			995
		Goodwill				753			753
		Other long-term assets				29			32
			Total assets		$	120,531		$	159,369

Liabilities and stockholder’s equity
	Current liabilities
		Accounts payable			$	4,392		$	4,718
		Accrued expenses				6,246			7,811
		Deferred revenue				305			305
		Current portion of long-term debt				257			295
			Total current liabilities			11,200			13,129
		Other long-term liabilities				166			220
		Deferred revenue				4,396			4,625
		Long-term debt				–			183
			Total liabilities			15,762			18,157
Stockholders’ equity
	Preferred stock, $0.00001 par value:
		Authorized: 5,000,000 and zero shares authorized at September 30, 2016 and
				December 31, 2015; no shares issued and outstanding as of September 30, 2016 and December 31, 2015		–			–
	Common stock, $0.00001 par value:
		Authorized: 200,000,000 shares at September 30, 2016 and December 31, 2015;
				42,758,693 and 41,110,127 shares issued and outstanding at September, 2016 and December 31, 2015, respectively		–			–
	Additional paid-in capital					472,778			467,075
	Accumulated deficit					(367,190	)		(325,342	)
	Accumulated other comprehensive loss					(819	)		(521	)
		Total stockholders’ equity				104,769			141,212
		Total liabilities and stockholders’ equity			$	120,531		$	159,369

CONTACT: Investor contact

Oksana Bradley

ir@conformis.com

(781) 374-5598

ConforMIS, Inc

DiscGenics Fortifies its Intellectual Property Portfolio with 9 Additional Patents

Posted On November 3, 2016 By OrthoSpineNews In Regulatory /

SALT LAKE CITY, Nov. 3, 2016 /PRNewswire/ — DiscGenics, Inc. (DiscGenics) announces the allowance of 9 additional patents that expand its intellectual property portfolio within both the U.S. and globally to 24 issued patents. The new patents include 2 in the U.S. and 7 in key European markets.

The patent portfolio provides coverage on its proprietary culture process and novel Discogenic Cell technology that is the therapeutic agent within its first product, Injectable Discogenic Cell Therapy (IDCT). The company is currently in the process of completing its preclinical development and looks forward to initiating initial human clinical trial during 2017 pending regulatory approvals.

About DiscGenics, Inc.

DiscGenics is a privately funded biotechnology company developing advanced spinal stem cell therapeutics to treat patients with diseases of the intervertebral disc. News and other information are available at: http://www.DiscGenics.com.

Media Contact: Bob Wynalek
Chief Operating and Commercialization Officer
801-410-0705
Bob@DiscGenics.com

SOURCE DiscGenics, Inc.

Integra LifeSciences Announces Plans for a Two-For-One Stock Split and Increase in Authorized Shares

Posted On November 3, 2016 By OrthoSpineNews In Financial /

PLAINSBORO, N.J., Oct. 27, 2016 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ:IART) today announced that its Board of Directors has recommended an increase in the number of authorized shares and a two-for-one stock split.

“The recommendation from the board of directors acknowledges the inflection point the Company has gone through and demonstrates their confidence in our long-term outlook,” said Peter Arduini, President and Chief Executive Officer, Integra Lifesciences. “This is the first increase in authorized shares in our 20-year history as a public company,” continued Mr. Arduini. “This authorization enhances our capital flexibility and better positions the Company for long-term growth.”

Stockholder approval is required for the proposal to amend the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 60,000,000 to 240,000,000 shares for the purpose of, among other things, effecting a two-for-one stock split (the “Amendment”). A special meeting of stockholders is expected to be held on Wednesday, December 21, 2016 at the Company’s Corporate Headquarters, 315 Enterprise Drive, Plainsboro, New Jersey.

If approved, the Company currently anticipates filing the Amendment with the Delaware Secretary of State on December 21, 2016. Holders of shares of the Company’s common stock at the time of the filing of the Amendment with the Delaware Secretary of State will be entitled to receive new shares, which are expected to be distributed on or about January 3, 2017.

Integra LifeSciences does not expect the stock split or increase in authorized shares to have any impact on 2016 financial performance.

About Integra

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for caregivers, so they can concentrate on providing the best patient care. Integra offers innovative solutions, including leading regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies. For more information, please visit www.integralife.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties and reflect Integra LifeSciences’ judgment as of the date of this release. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ from predicted results. These risks and uncertainties include market conditions and other factors beyond Integra LifeSciences’ control and the economic, competitive, governmental, technological and other factors identified under the heading “Risk Factors” included in item 1A of Integra LifeSciences’ Annual Report on Form 10-K for the year ended December 31, 2015, and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results. These forward-looking statements are made only as the date thereof, and Integra LifeSciences undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Integra LifeSciences Holdings Corporation

Investor Relations: 
Angela Steinway
(609) 936-2268
angela.steinway@integralife.com 

Michael Beaulieu
(609) 750-2827
michael.beaulieu@integralife.com

Scientists develop new implant coating derived from mussels

Posted On November 3, 2016 By OrthoSpineNews In Biologics /

November 2, 2016

A team of Japanese researchers has pioneered a new method for improving the biocompatibility of implant surfaces based on the chemical properties of mussels. The study contributes to a field of research that is exploring the use of proteins to ‘immobilise’, or fix, organic cells to metal surfaces.

The authors, based at the RIKEN research institute, Saitama, Japan, identified the natural adhesive properties of mussels as a potential method for improving attachment to metal surfaces. These molluscs use protein secretions to tightly bond their cells with surfaces, including metallic or ceramic ones, and can retain this grip even when submerged under water. The team identified that advances in controlling gene expression may enable them to activate the binding property of specific proteins, which could then be applied to implant surfaces.

The key chemical in the reaction is dopamine (3,4-dihydroxyphenethylamine) which had not previously been integrated into protein-based growth factors for use on implant surfaces. However, the scientists were concerned that the direct incorporation of such a chemical may compromise the protein’s underlying structure, negating the effect.

An innovative two-stage engineering method was devised by the team to express dopamine in a growth factor. The non-intrusive chemical tyrosine was incorporated into the protein, which was subsequently mixed with the enzyme tyrosinase. Tyrosinase has been used in other research to convert tyrosine into dopamine. In this case, the reaction took place without unsettling the tertiary structure of the protein, and dopamine was safely generated within it – closely matching that of the underwater adhesive secreted by mussels.

The authors tested the chemical by applying it to titanium-coated discs. Titanium is commonly used for many medical devices including dental implants. After applying the modified growth factor, significantly enhanced cell growth was observed on the surface of the discs as well as improved cell binding properties.

This outcome could have an impact on implant procedures, as cells may bond with implant surfaces more easily if they are coated with the treated growth factor. As well as having applications in implant dentistry, the new method for expressing dopamine in growth-factor proteins could be harnessed in regenerative medicine and cell culture systems. The study was published in Angewandte Chemie.

Intellijoint Surgical® Raises $11M to Expand the US Launch of intellijoint HIP®

Posted On November 3, 2016 By OrthoSpineNews In Financial, Recon /

November 1, 2016 (Waterloo, Ontario) – Intellijoint Surgical®, Inc., an innovative medical technology company that develops and commercializes 3D mini-optical navigation solutions for surgery, is excited to announce the completion of its Series A with $11MM in financing. The Series A was led by private investors from the Waterloo-Toronto corridor and closed in multiple tranches. Intellijoint is committed to improving patient outcomes through innovative technology made accessible for every patient, every surgeon and every healthcare facility.

“The US launch of the next generation intellijoint HIP® earlier this year is being extremely well received in the marketplace and is seeing significant growth,” commented Intellijoint Surgical® CEO and Co-Founder, Armen Bakirtzian. “This Series A capital will allow Intellijoint to enhance its product offering with the Direct Anterior Approach Application and allow for expansion into new US markets while enabling deeper penetration of Intellijoint’s presence in New York and Illinois.”

Intellijoint Surgical’s flagship product, intellijoint HIP®, is a mini-optical navigation solution that assists orthopaedic surgeons in reaching preoperative surgical targets by providing real-time, intraoperative measurements for cup position, leg length, offset and hip center of rotation during a Total Hip Arthroplasty (THA). intellijoint HIP® has been used in over 500 procedures in Canada and US, and is both Health Canada licensed and FDA approved.

“Intellijoint has addressed the shortcoming of traditional navigation. The miniature optical camera provides accurate measurements while compensating for patient movement, which is routine during a total hip replacement. It provides me with valuable information and I choose to use it in every case,” added Dr. Wayne Paprosky, Midwest Orthopaedics at Rush and member of Intellijoint’s scientific medical advisory board.

About Intellijoint Surgical, Inc.

Intellijoint Surgical® develops and commercializes surgical navigation solutions. Intellijoint’s flagship product, intellijoint HIP® provides surgeons with real-time, intraoperative measurements to ensure proper positioning of orthopaedic implants during Total Hip Arthroplasty. Intellijoint is committed to driving clinical results through the development of solutions that are accessible, fast, and easy-to-use. Guided by a scientific advisory board comprised of Dr. Allan Gross, an orthopaedic surgeon at Mount Sinai Hospital, and members, Dr. Javad Parvizi at Thomas Jefferson University Hospital, Dr. Michael Cross at Hospital for Special Surgery, Dr. Wayne Paprosky at Rush University Medical Center, and Dr. Ran Schwarzkopf at NYU School of Medicine, Intellijoint is setting the new standard in miniature 3D surgical navigation.

Intellijoint Surgical has plans to use its core technology to expand into other orthopaedic procedures.

Intellijoint Surgical is the recipient of the 2015 North American Frost & Sullivan Enabling Technology Leadership Award and the Futurpreneur Shopify True Grit Award 2016.

For more information, please visit: www.intellijointsurgical.com

Orthopaedics giant Smith & Nephew to open £8m R&D centre in Hull

Posted On November 3, 2016 By OrthoSpineNews In Financial /

3 NOVEMBER 2016 – By Julia Bradshaw

Smith & Nephew, the global medical devices company, will open a state-of-the-art research and development centre in Hull, creating 100 jobs.

Despite the outcome of the EU referendum, the company has decided to invest $10m (£8m) in a brand new European ‘medtech’ centre, to be located in the UK.

The facility will conduct research across all of Smith & Nephew’s divisions, with a focus on wound dressings in particular.

It will employing 100 scientists and other staff, including toxicologists, chemists and engineers. Some will be new roles, while others will be transferred from existing sites in York and the US.

The facility will open in the second quarter of 2017 and chief executive Olivier Bohuon said there would be room to grow the headcount.

He said the orthopaedics giant could have opened the lab anywhere in Europe, but chose the UK.

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Medovex Corporation Announces Successful Largest Living Tissue Population Test to Date

Posted On November 3, 2016 By OrthoSpineNews In Spine /

ATLANTA, GA–(Marketwired – Nov 2, 2016) – Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that the company conducted a successful live tissue test of the DenerveX™ System under the most stringent standards required by FDA and other regulatory agencies.

Patrick Kullmann, Medovex President and COO, stated, “This latest testing of the DenerveX System is the largest living tissue population test to date. The results confirm that the DenerveX System delivers its intended treatment and that it supports the type of reimbursement that the company has already secured in its first targeted country, Germany.”

The GLP (Good Laboratory Practice) protocol testing consisted of a 12 porcine subject clinical evaluation of the DenerveX System at 0, 30 and 60 day time period post procedure. The total subject pool consisted of 144 treatments, of which 48 treatment sites were randomly selected and initially evaluated per the GLP.

Of the 48 evaluated treatments, 92% of the DenerveX System treatments reached their targeted facet joint treatment sites. Dorsal nerve roots and dorsal ganglia did not have evidence of neurodegeneration at the sites examined. No routinely examined organs had changes interpreted to be related to the study. All subjects survived the study to term absent complication.

Martin Deeg MD of Stuttgart, Germany an advisory board member with experience with the DenerveX System, reviewed the data and stated, “The DenerveX System delivered treatments that would be expected and desired as needed to provide longer term pain relief, and that would set up the DenerveX System and procedure as a new and unique therapy for Facet Joint Syndrome.”

Vik Kapoor MD of Manchester, England, also an advisory board member and equally experienced with the DenerveX System, added, “The DenerveX System proved out in the data that it will fundamentally change the way Facet Joint Syndrome will be treated in the future.”

Jarrett Gorlin, Medovex CEO, commented, “The DenerveX System represents a very new and creative approach in treating pain associated with the Facet Joint Syndrome. Our future customers have commented their clear appreciation for our different approach in performing a new procedure by way of a posterior calsulectomy of the facet joint, compared to the less effective standard radio frequency ablation (Rhizotomy). This gives us cause for continued cautious optimism going forward.”

The DenerveX System consists of the DenerveX device, a single use medical device and the DenerveX Pro-40 Power Generator, both designed to be less invasive with faster recovery time than current surgical treatment options. It consists of two procedures combined into one device and is expected to provide for a longer lasting treatment solution while offering potential savings to the health care system. DenerveX is not yet commercially available.

DenerveX System is not yet CE marked or FDA cleared and is not yet commercially available. A full evaluation of the test results continues. The results of the test have not yet been submitted to, or evaluated by, the notified body or FDA for consideration and comment. There can be no assurance that the notified body or FDA will not have further questions or require additional information when it reviews the test results.

About Medovex

Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com

Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

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Jason Assad
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Month: November 2016

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