Archive for the ‘Member Press Releases’ Category

Safis Clients Receive Two More FDA Market Clearances!

October 9, 2014

October 7, 2014 – Indianapolis, IN. Safis Solutions is announcing more marketing clearances for its clients – Stereotaxis, Inc. (Nasdaq: STXS), headquartered in St. Louis and Biomedix, Inc. located in Bloomington, Indiana that have received recent 510k clearances from the Food and Drug Administration (FDA).

 

Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. It was announced earlier this month that the company received approval for its Vdrive™ Robotic Navigation System with V-Loop™ Variable Loop Catheter Manipulator. This is the second FDA clearance for the Vdrive family of products, the first of which came in July of 2013 and was for the Vdrive with V-Sono™ system. Karen Duros, Stereotaxis Senior Vice President & General Counsel said, “This is another important step for Stereotaxis in bringing our Vdrive products to market in the U.S. We have a great deal of confidence in Safis’ ability to deliver and we are pleased that our regulatory program is in good hands.”

 

Early in 2014, Safis was hired by Biomedix, Inc. of Bloomington, IN to help with an important regulatory submission. On Friday August 8, 2014 Biomedix received a Special 510(k) clearance from the FDA for its SELEC-3® I.V. Administration Set. Biomedix manufactures IV fluid delivery sets for hospitals and emergency first-responders. After the submission was cleared, Biomedix President Myra Bender said she “felt relieved” and that a “huge weight was lifted.” She went on to say, “We couldn’t have done it without Safis’ team. I can’t tell you how pleased I am that everything worked out. I do feel that I hired the right company. Biomedix is eager to resume distribution of all the unique designs of our SELEC-3® I.V. Administration Sets.”

 

John Nadelin, Vice President of Regulatory & Compliance at Safis, leads the service delivery teams and expressed, “We have a lot of gratitude for our role with companies like Biomedix and Stereotaxis. When approvals like this happen, we are reminded of how our work plays a crucial role in patients’ lives.”

 

Safis Solutions is a regulatory and quality compliance consulting firm for life science clients worldwide, and the regulatory submission success rate has been 100%. Services successfully executed by Safis have helped more than 150 clients over the past 12 years, meeting regulatory compliance and GxP quality standards and gaining government agency approvals for medical products, manufacturing systems, clinical and laboratory systems.

 

Ping Poulsen, President and CEO of Safis Solutions, was very pleased with the high quality performance by Safis’ teams. When congratulated on Safis’ success, she commented “it was not me, it was the team work. I am very fortunate to be surrounded by more successful professionals.”

 

Safis originated from the Indiana University Emerging Technologies Center (IUETC) and has been certified as WBE by WBENC, MBE by MSDC, both MBE and WBE by the state of Indiana and the city of Indianapolis. For more information, contact Thomas (Tom) Stergar II at 317-777-6203.

ENHANCING THE PERFORMANCE AND RELIABILITY OF MANUFACTURING OPERATIONS AND CRITICAL FACILITIES

October 1, 2014

CAI good

FOR IMMEDIATE RELEASE

Media Contact(s): Jackie Weichman, Manager, Global Marketing

Jackie.Weichman@cagents.com

 

Richard Tree takes the reins as CAI Director of Maintenance and Reliability.

 

INDIANAPOLIS, IN – 01 October 2014 – Commissioning Agents, Inc. announces the addition of Richard Tree to our senior leadership. As Director of Maintenance and Reliability, Richard will be responsible for growing the CAI Maintenance and Reliability business area and administering global quality standards. This leadership includes developing business direction and agenda, strategic planning, tactical guidance, and management.

 

Robert Chew, President and CEO of Commissioning Agents, Inc. stated, “Richard has three decades of operations and maintenance experience – spanning nuclear submarines to temporary construction office modules. Richard brings both a discipline and pragmatism to how maintenance and reliability programs should be designed and implemented. He understands all aspects of maintenance as a means to an operational end – from making the business case to the deployment of a culture of performance and reliability. We look forward to furthering this dimension of our services.”

 

Of his new role, Richard stated, “I’m thrilled to be given the opportunity to work for such a great company where I can contribute my expertise to an already highly talented and well regarded team. There has never been a better time to help companies across all industries around the globe realize the benefits of a formal strategy for managing their assets. Firms continually find themselves in some stage of planning, acquiring, operating, maintaining, rehabilitating, replacing, and disposing of assets. The key is to do all of these activities in the most cost effective manner, without sacrificing quality, safety, and sustainability. It is this core principle that forms the substance of what our M&R teams bring to customers.”

 

Richard has 31 years of experience: 22 years of submarine naval nuclear power operations, and 9 years overseeing manufacturing operations in the private sector. He is a recognized for operations excellence and has held leadership roles as VP of Operations and Chief Operating Officer where he was responsible for multi-site manufacturing plants and their supply chains. He is Lean Six Sigma Certified and has authored multiple articles for industry publications. Some of Richard’s most impactful work was in the area of Enterprise Asset Management involving asset and system design, sourcing, life cycle management, and reliability. His approach to asset life cycle management is one that develops a framework for continuous improvement based on the business’ objectives for their value added needs. His efforts led to dramatic gains in operating equipment effectiveness (OEE) from as low as 40% to as high as 90% as a result of improved reliability. Richard holds an MBA from Southern Methodist University and is currently working on his PhD dissertation in the field of Operations Management from the University of Texas Arlington.

 

Commissioning Agents Inc. is an employee-owned company headquartered in Indianapolis, Indiana, USA. We provide technical and consulting services that promote the delivery, reliability and efficiency of equipment, facilities, and production operations. Visit our website at http://www.commissioningagents.com for additional information.

 

Partnership Re-Launches SBIR/STTR Matching Program and Provides No-Cost Technical Assistance for SBIR Proposals

July 30, 2014

Indiana Office of Small Business and Entrepreneurship

Jacob Schpok, Executive Director

FOR IMMEDIATE RELEASE

INDIANAPOLIS (July 30, 2014) – Lt. Governor Sue Ellspermann announced today a partnership between the Indiana Economic Development Corporation (IEDC) and the Office of Small Business and Entrepreneurship (OSBE) which will provide technical writing assistance to Hoosier entrepreneurs for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) proposals. The same initiative will also re-launch Indiana’s Phase I matching program.

 

Lt. Governor Ellspermann noted, “Hoosier entrepreneurs and small business owners are keys to the continued economic growth and vitality of our State.  Providing technical support to access funding for innovation and technology transfer is another type of assistance that moves businesses forward.”

 

“The next great business idea is developing in the mind of a Hoosier,” said Eric Doden, president of the IEDC. “It is our priority to make sure that idea is brought to life in Indiana, with the right support system in place to help our entrepreneurs grow their ideas into high-performing businesses. The entrepreneurial spirit thrives in Indiana, with a business climate built on innovation here in a state that works.”

 

Through this partnership, Indiana companies can receive up to $5,000 in proposal writing or market research assistance from SBIR writing experts up to two times per SBIR/STTR agency. Indiana companies may also receive up to $500 in proposal review services. To learn more about this service, visit http://www.indianaptac.com/sbirsttr/.

 

Companies interested in Phase I matching can access up to an additional 50 cents for every federal dollar, up to $50,000 per award, subject to funding availability and eligibility determination. To apply for matching funds, please contact Elevate Ventures (www.elevateventures.com).

 

The highly competitive SBIR program encourages domestic small businesses to engage in Federal Research and Development that has potential for commercialization. This enables small businesses to explore new technologies by providing the incentive of profit from commercialization.

 

About IEDC

Created in 2005 to replace the former Department of commerce, the Indiana Economic Development Corporation is governed by a 12-member board chaired by Governor Mike Pence. Victor Smith serves as the Indiana Secretary of Commerce and Eric Doden is the president of the IEDC.

 

The goal of Indiana’s 21st Century Research & Technology Fund is to support the resolution of next-stage capital formation issues by co-investing with institutional investors in order to further build innovative, high-impact, high-growth companies. Indiana’s 21 Fund is managed by Elevate Ventures.

 

About OSBE

Under the leadership of Lt. Governor Sue Ellspermann, the Indiana Office of Small Business and Entrepreneurship (OSBE) oversees the Indiana Small Business Development Center (ISBDC), the Procurement Technical Assistance Center (PTAC), and the Indiana Small Business Ombudsman. The OSBE staff helps grow the Indiana economy by assisting entrepreneurs and small businesses through programs and personal consultation. For more information on OSBE and to see how Indiana is “the state that works” for entrepreneurs visit www.osbe.in.gov.

 

-30-

 

Media Contacts:

Erik Scheub (OSBE) – 317.232.5679 or erscheub@osbe.in.gov

Office of the Lieutenant Governor – 1 North Capitol, Suite 600, Indianapolis, IN 46204, (317) 234-2082

osbe.in.gov

Pearl Pathways Honored as One of the 2014 Indiana Companies to Watch

July 21, 2014

PearlPathways

July 17, 2014

FOR IMMEDIATE RELEASE

Contact: Diana Caldwell
Pearl Pathways
Business: (317) 899-9341
contact@pearlpathways.com
www.pearlpathways.com

Pearl Pathways Honored as One of the 2014 Indiana Companies to Watch

INDIANAPOLIS, Ind. (July 17, 2014)– Pearl Pathways has been recognized as one of the 2014 Indiana Companies to Watch, an awards program presented by the Indiana Office of Small Business and Entrepreneurship (OSBE), its Indiana Small Business Development Center, the Indiana Economic Development Corporation (IEDC), and endorsed by the Edward Lowe Foundation.

Twenty-seven companies from Indiana will be honored as outstanding second-stage companies during the fifth annual Indiana Companies to Watch awards program, held on August 20 in Indianapolis.

Companies to Watch is an awards program that celebrates Indiana’s privately-held second-stage companies, those businesses that are past the startup phase, are considered to be established, and face issues of growth, not survival.

Companies honored range in industries and have headquarters based in 12 counties throughout the state. Among the 27 honored companies in 2014 is Pearl Pathways.

About Pearl Pathways

Pearl Pathways is a comprehensive life science product development services company. Our experienced team is obsessed with expediting life science product development regulatory pathways. We have three business units to serve you:

  • Pearl IRB is a full service commercial Independent Review Board that provides human research IRB reviews, IRB exemptions and waivers, and also offers support for research protocol/ICF medical writing, site assessments, and monitoring services.
  • Pearl ReGXP is a regulatory and quality compliance consulting practice that provides regulatory filing guidance, conducts global health authority negotiations, develops/improves quality systems, and delivers GMP/GLP/GCP auditing services.
  • Pearl IDEAS provides strategic product development assistance, third party vendor selection and management strategies, due diligence services, and sales and marketing services for drug, biologic and device companies.

From 2010 through 2013, these companies generated $379 million in revenue and added 622 employees (both in Indiana and out of state), reflecting a 120 percent increase in revenue and 96 percent increase in jobs for the four-year period. That translates into a 40 percent annual revenue growth and 32 percent annual growth in employees.

These companies project continued growth in 2014, with a 50 percent revenue increase and 26 percent growth in employees (both in Indiana and out of state) compared to 2013. If their projections hold, these companies will have generated $612 million in revenue and added 764 employees over the last five years — a 301 percent increase in revenue and 185 percent increase in jobs since 2010.

This program would not be possible without the generous support of the Indiana Economic Development Corporation and endorsed by the Edward Lowe Foundation. Sponsors include the Barnes & Thornburg, Katz Sapper & Miller, Key Bank and Ivy Tech Corporate College.

Companies to Watch firms must employ between six and 150 full-time equivalent employees, have between $750,000 and $100 million in annual revenue or working capital in place, and demonstrate the intent and capacity to grow based on employee or sales growth, exceptional entrepreneurial leadership, sustainable competitive advantage or other notable strengths.

About OSBEv
Under the leadership of Lt. Governor Sue Ellspermann, the Indiana Office of Small Business and Entrepreneurship (OSBE) oversees the Indiana Small Business Development Center (ISBDC), the Procurement Technical Assistance Center (PTAC), and the Indiana Small Business Ombudsman. The OSBE staff helps grow the Indiana economy by assisting entrepreneurs and small businesses through programs and personal consultation. For more information on OSBE and to see how Indiana is “the state that works” for entrepreneurs visit www.osbe.in.gov.

About the ISBDC
As part of OSBE, the ten Indiana Small Business Development Centers (ISBDC) support the formation, growth, and sustainability of Indiana’s small businesses by providing entrepreneurs expert guidance and access to a network of resources. Funding for the regional ISBDCs comes from state universities, chambers of commerce, economic development offices, mayor offices, and banks. Statewide financial support is provided by U.S. Small Business Administration, the State of Indiana and Ivy Tech Community College.  Administratively, the ISBDC Lead Center is operated by the Office of Small Business and Entrepreneurship (OSBE), an agency of the Office of Lt. Governor Sue Ellspermann. To learn more about the ISBDC and to become a client visit: http://isbdc.org.

About Indiana Companies to Watch
Indiana Companies to Watch is an awards program celebrating second-stage entrepreneurs presented by the Office of Small Business and Entrepreneurship, its Small Business Development Center, the Indiana Economic Development Corporation and endorsed by the Edward Lowe Foundation. Sponsors include the Barnes & Thornburg, Katz Sapper & Miller, Key Bank and Ivy Tech Corporate College.

To learn more, please visit us at www.pearlpathways.com, call us at (317) 899-9341, or email contact@pearlpathways.com. Pearl Pathways is located in Indianapolis, Indiana, and is a WBENC certified woman owned business. For media inquiries, contact Diana Caldwell at dcaldwell@pearlpathways.com.

SAMSUNG

Safis clients win market clearance!

November 12, 2013

Contact:
Thomas (Tom) Stergar II
FOR IMMEDIATE RELEASE
Office: 317-777-6203
Cell:317-697-9988
tstergar@safis-solutions.com
October 29, 2013

Safis Solutions is announcing that two of its clients, Stereotaxis, Inc. (Nasdaq:STXS) and Dermal Life LLC, are cleared to market four products by 510(k) approval from the Food and Drug Administration (FDA). Stereotaxis, St. Louis, MO., is marketing its Vdrive™ Robotic Navigation System with V-Sono™ Intracardiac Echocardiography (ICE) catheter manipulator to help improve the efficiency of cardiac catheterization procedures. This represents the first FDA clearance for the Vdrive family of products, which has been utilized in Europe since 2011. Karen Duros, Senior Vice President & General Counsel, said, “Safis helped lead us through this crucial regulatory hurdle. They are a trusted partner and valued member of the Stereotaxis Team, and we are grateful for their involvement.” The Safis team was led by John Nadelin, Vice President of Regulatory & Compliance. Nadelin expressed, “We are very happy for Stereotaxis. It is very gratifying to be part of the Stereotaxis team whose work is important to improving the lives of not only thousands of cardiac patients, but the physicians that perform these delicate procedures.” Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab.

Dermal Life LLC, a Florida company founded in 2010 and also a Safis client, has a mission to develop advanced skin care products that maximize skin health. In May 2013, Dermal Life received FDA 501(k) clearance for Hydropermeate™ Topical Emulsion (Rx) with indications for full-thickness wounds, pressure sores, dermal ulcers, including lower leg ulcers; superficial wounds; 1st and 2nd degree burns, including sunburns; dermal donor and graft site management; radiation dermatitis; and minor abrasions. Additionally, Dermal Life received FDA clearance for Answer2Skin™ Sunburn Relief Cream (OTC) for minor burns, including minor sunburns, and Answer2Skin™ First Aid Cream (OTC) for minor superficial wounds and minor abrasions, including cuts and scrapes. Randy Hitchens, Senior Vice President Business Development, reports that “Dermal Life leveraged the regulatory and quality skills of Safis Solutions to select our CMO partner, develop our formulation, create lab-validation-stability batches, pass required-FDA toxicology testing, successfully complete stability testing, file our FDA 510(k) application, respond to FDA requests for additional information and achieve FDA clearance in a 2.5 year period. Our team was highly impressed with the Safis Solutions team of Ping Poulsen, John Nadelin, John Lockwood and John Steichen. Dermal Life has actively recommended Safis Solutions to other health care companies.

Safis Solutions provides consulting services in the areas of regulatory affairs, quality compliance (cGxP), audits, computer system validation, and IT services for pharmaceutical, medical device and biotechnology clients worldwide. Services successfully executed by Safis have helped more than 150 clients over the past 11 years meet regulatory compliance and quality standards and gain government agency approvals for their products, manufacturing systems, clinical and laboratory systems. Safis originated at the Indiana University Emerging Technologies Center (IUETC), and has been certified as WBE by WBENC, MBE by MSDC, both MBE and WBE by the state of Indiana and the city of Indianapolis.

For more information, contact Thomas (Tom) Stergar II at 317-777-6203.

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ASH Consulting Goes After Chase Mission Main Street Grant

November 5, 2013

Please vote for ASH Consulting to win a Chase Mission Main Street Grant!

The $250,000 grant will allow David Woll and Aleta Hodge to collaborate to present seminars for college students on early stage funding opportunities in 2014 and 2015! Our target population will consist of women and under-served small business owners.

 

You can vote by either using Facebook or the ASH Consulting Web page

  1. https://facebook.com/ashconsult5

(In lower right hand corner, click on Chase Mission Main Street Grants)

 

  1. http://www.ashconsult5.com

(links to Chase site & then click on Vote Now button, you must vote

via your Facebook account)

 

Voting period runs until Nov. 15th!

Ivy Tech Fall Life Science Classes Now Available

August 26, 2013

Ivy Tech Corporate College just released its fall catalog. Two courses may be of particular interest to companies and individuals in the life science sector.

Regulatory Affairs Overview

This 9-contact hour course will provide an overview of the laws and regulations that govern the life sciences industry. This course will provide a brief introduction to the regulatory environment for employees in the biosciences sector who do not work in the Regulatory department of your company. The course is scheduled to run on 3 Wednesday afternoons in September.

Biomanufacturing Overview. This 9-contact hour course is intended to provide an overview of the biotechnology industry. This course is designed for more of a general audience, such as your friends and neighbors who may be curious about the industry and who might wonder if a career in it is right for them. This course is scheduled to run on 3 Thursday evenings in October.

 

These courses are listed on page 6 of the catalog, which you can click here to download. There is a registration form in the front of each catalog or you can register at www.ivytech.edu/bloomington/corporate-college.

 

Please contact Clint Merkel, Director, Indiana Center for Life Sciences, Ivy Tech Bloomington  or call 812-330-6065 if you have any questions.

 

 

 

Purdue Technology Road Show

August 21, 2013

Presented by the

Purdue Office of Technology Commercialization and

Purdue Research Park of Northwest Indiana

You are cordially invited to the

Purdue Technology Road Show

featuring new innovations developed at Purdue University

September 18, 2013 12:30 p.m. to 3:30 p.m.

Purdue Technology Center of Northwest Indiana

9800 Connecticut Drive Crown Point, Indiana

Event is free and includes lunch. Please RSVP by September 11

to Sally Ross at (765) 588-3490, saross@prf.org. Seating is limited.

DuPont and IQLP Ink Deal to Develop High-Speed Circuit Technology

August 8, 2013

Liquid Crystal Polymer to Target High-Frequency Film Market 

 

DuPont Circuit & Packaging Materials (DuPont) and IQLP, LLC, a division of Interplex Industries, Inc., announced their ongoing efforts to further develop and refine liquid crystal polymer (LCP) thin-film technology for use in high-speed circuit applications.

Read the full Dupont press release here

Click here for more info on IQLP

www.interplex.com

Notre Dame Announces Biomedical Imaging Partnership – Newsroom – Inside INdiana Business with Gerry Dick

July 26, 2013

Notre Dame Announces Biomedical Imaging Partnership – Newsroom – Inside INdiana Business with Gerry Dick.

 

SOUTH BEND, Ind. – The University of Notre Dame has established a formal partnership with Bruker Corp., a world leader in scientific instrumentation. The partnership will develop one of the Midwest’s top imaging facilities at Notre Dame. The arrangement, called Bruker at Notre Dame (BAND), will allow the Notre Dame Integrated Imaging Facility (NDIIF) and Bruker to collaborate on research, training and new application development.


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